HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2018-04088
- Event Type
- Death
- Date Received
- August 27, 2018
- Date of Event
- August 5, 2018
- Report Date
- December 9, 2021
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000017
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1336-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL EVENT INFORMATION. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: CON308662 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H6: PATIENT IME CODE(S): E2402 H6: IMF CODE(S): F02 H6: FDA DEVICE CODE(S): A040609, A23 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER AC ADAPTER D4: MODEL #: UNK / CATALOG #: UNK / EXPIRATION DATE: UNK / SERIAL OR LOT#: UNK UDI #: ASKU D9: NO H4: MFG DATE: UNK H5: NO H6: PATIENT IME CODE(S): E2402 H6: IMF CODE(S): F02 H6: FDA DEVICE CODE(S): A0708 H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16 INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION.MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE RECALL NUMBER. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
###A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE ANALYSIS. PRODUCT EVENT SUMMARY: ONE (1) VENTRICULAR ASSIST DEVICE (VAD) AND ONE (1) CONTROLLER WERE RETURNED FOR EVALUATION. THE CONTROLLER AC ADAPTER WAS NOT RETURNED FOR EVALUATION. A REVIEW OF (B)(6) MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED A BENT PIN WITHIN POWER PORT TWO (2) OF THE CONTROLLER. THE BENT PIN DID NOT ALLOW A BATTERY TO PROPERLY CONNECT TO THE CONTROLLER. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION, FUNCTIONAL TESTING, AND DIMENSIONAL VERIFICATION. INTERNAL PATHOLOGICAL REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE DEVICE. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE OF A MALFUNCTION THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT EXPERIENCED A LOSS OF POWER RESULTING IN A PUMP STOP AND WAS FURTHER FOUND DEAD AT HOME. ADDITIONAL INFORMATION RECEIVED BY THE SITE REVEALED THAT THE CONTROLLER AC ADAPTER WAS WAS TIGHTLY STRETCHED THROUGH SOME BEDDING AND UNDER THE MATTRESS AND AROUND THE BEDSIDE TABLE, BUT THE PRONGS WERE NOT FULLY PLUGGED INTO THE ELECTRICAL STRIP. LOG FILE ANALYSIS REVEALED 6 CONTROLLER POWER-UP EVENTS LOGGED ON (B)(6) 2018 AT 08:53:23, ON (B)(6) 2018 AT 10:09:54, ON (B)(6) 2018 AT 07:42:15, 07:42:35 AND 07:45:16, AND ON (B)(6) 2018 AT 15:22:05. THE DATA POINT PRIOR TO THE 16-AUG-2018 CONTROLLER POWER-UP EVENT, LOGGED ON THE CONTROLLER'S INTERNAL LOGS ON 12-AUG-2018 AT 07:40:04, REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT 1 WITH 98% RELATIVE STATE OF CHARGE (RSOC) AND (B)(6) WAS CONNECTED TO POWER PORT 2 WITH 90% RSOC. THE DATA POINT AFTER THE CONTROLLER POWER UP EVENT, LOGGED ON 16-AUG-2018 AT 15:22:41, REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT 1 AND NO POWER SOURCE WAS CONNECTED TO POWER PORT 2. NO ANOMALIES WERE OBSERVED PRIOR TO THE RECORDED CONTROLLER POWER-UP EVENTS. THE CONTROLLER WAS WITHOUT POWER FOR 14 SECONDS, 17 SECONDS, A MAXIMUM OF 3 MINUTES AND 26 SECONDS FOR THE (B)(6) 2018 POWER UPS, AND APPROXIMATELY 4 DAYS, 7 HOURS, 36 MINUTES AND 49 SECONDS; RESPECTIVELY. AS A RESULT, THE REPORTED LOSS OF POWER AND CONTROLLER BENT PIN EVENTS WERE CONFIRMED. THE REPORTED "CONTROLLER AC ADAPTER UNPLUGGED AND NOT PROVIDING POWER" EVENT COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER EVENTS OBSERVED ON (B)(6) 2018 THROUGH (B)(6) 2018 CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER EVENT OBSERVED ON (B)(6) 2018 CAN BE ATTRIBUTED TO A DISCONNECTION OF ONE OR BOTH POWER SOURCES; ITS IS POSSIBLE THE REPORTED UNPLUGGED CONTROLLER AC ADAPTER CONTRIBUTED TO THE OBSERVED LOSS OF POWER EVENT. THE MOST LIKELY ROOT CAUSE OF THE BENT PIN CAN BE ATTRIBUTED TO A MISALIGNMENT BETWEEN THE POWER PORT AND BATTERY OUTPUT CONNECTOR. AN INTERNAL INVESTIGATION WAS OPENED TO EVALUATE BENT/DAMAGED PINS WITH CONTROLLER 2.0. PER THE INSTRUCTIONS FOR USE, DEATH IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL PRODUCTS: D4: MODEL #: CAC-ADAPTER / SERIAL OR LOT#: UNK H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D12, D14 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED.### MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR INVESTIGATION COMPLETE. PRODUCT EVENT SUMMARY: VENTRICULAR ASSIST DEVICE (VAD) (B)(6) AND ONE (1) CONTROLLER (B)(6) WERE RETURNED FOR EVALUATION. THE CONTROLLER AC ADAPTER WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. A REVIEW OF(B)(6) MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED A BENT PIN WITHIN POWER PORT TWO (2) OF THE CONTROLLER. THE BENT PIN DID NOT ALLOW A BATTERY TO PROPERLY CONNECT TO THE CONTROLLER. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION, FUNCTIONAL TESTING, AND DIMENSIONAL VERIFICATION. INTERNAL PATHOLOGICAL REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE DEVICE. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE OF A MALFUNCTION THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT EXPERIENCED A LOSS OF POWER RESULTING IN A PUMP STOP AND WAS FURTHER FOUND DEAD AT HOME. ADDITIONAL INFORMATION RECEIVED BY THE SITE REVEALED THAT THE CONTROLLER AC ADAPTER WAS TIGHTLY STRETCHED THROUGH SOME BEDDING AND UNDER THE MATTRESS AND AROUND THE BEDSIDE TABLE, BUT THE PRONGS WERE NOT FULLY PLUGGED INTO THE ELECTRICAL STRIP. ADDITIONALLY, THE PATIENT'S DEATH WAS RELATED TO AN ACCIDENTAL CONTROLLER DISCONNECT. LOG FILE ANALYSIS REVEALED 6 CONTROLLER POWER-UP EVENTS LOGGED ON (B)(6)2018AT 08:53:23, ON (B)(6)2018 AT 10:09:54, ON (B)(6)2018 AT 07:42:15, 07:42:35 AND 07:45:16, AND ON (B)(6)2018 AT 15:22:05. THE DATA POINT PRIOR TO THE (B)(6)2018 CONTROLLER POWER-UP EVENT, LOGGED ON THE CONTROLLER'S INTERNAL LOGS ON (B)(6)2018 AT 07:40:04, REVEALED THAT BAT551508 WAS CONNECTED TO POWER PORT 1 WITH 98% RELATIVE STATE OF CHARGE (RSOC) AND BAT551216 WAS CONNECTED TO POWER PORT 2 WITH 90% RSOC. THE DATA POINT AFTER THE CONTROLLER POWER UP EVENT, LOGGED ON (B)(6)2018 AT 15:22:41, REVEALED THAT BAT551246 WAS CONNECTED TO POWER PORT 1 AND NO POWER SOURCE WAS CONNECTED TO POWER PORT 2. NO ANOMALIES WERE OBSERVED PRIOR TO THE RECORDED CONTROLLER POWER-UP EVENTS. THE CONTROLLER WAS WITHOUT POWER FOR 14 SECONDS, 17 SECONDS, A MAXIMUM OF 3 MINUTES AND 26 SECONDS FOR THE (B)(6)2018 POWER UPS, AND APPROXIMATELY 4 DAYS, 7 HOURS, 36 MINUTES, AND 49 SECONDS: RESPECTIVELY. AS A RESULT, THE REPORTED LOSS OF POWER AND CONTROLLER BENT PIN EVENTS WERE CONFIRMED. THE REPORTED "CONTROLLER AC ADAPTER UNPLUGGED AND NOT PROVIDING POWER" EVENT COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER EVENTS OBSERVED ON (B)(6)2018 THROUGH (B)(6)2018 CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER EVENT OBSERVED ON (B)(6)2018 CAN BE ATTRIBUTED TO A DISCONNECTION OF ONE OR BOTH POWER SOURCES; IT IS POSSIBLE THE REPORTED UNPLUGGED CONTROLLER AC ADAPTER CONTRIBUTED TO THE OBSERVED LOSS OF POWER EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00384004, THE ROOT CAUSE OF BENT SOCKET PINS WITHIN POWER PORT CONNECTORS IS ATTRIBUTED TO MISALIGNMENT DURING CONNECTION ATTEMPTS BETWEEN THE METAL RECEPTACLES ON THE CONTROLLER AND THE PLASTIC CONNECTOR PLUGS IN THE BATTERY AND/OR ADAPTER CABLES. THE MISALIGNMENT RESULTS IN WEAR ON THE CONNECTOR PLUGS THAT CAN LEAD TO CONTACT BETWEEN THE CONNECTOR PLUG AND SOCKET PINS FROM THE CONTROLLER. THE SOCKET PINS MAY NOT WITHSTAND APPLIED FORCES FROM SUBSEQUENT MISALIGNED CONNECTIONS, CAUSING THE PINS TO BEND. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, DEATH IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE IS POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) AND THE CONTROLLER WERE RETURNED FOR EVALUATION. A REVIEW OF THE VAD¿S MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED A BENT PIN WITHIN POWER PORT TWO OF THE CONTROLLER. THE BENT PIN DID NOT ALLOW A BATTERY TO PROPERLY CONNECT TO THE CONTROLLER. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE BENT PIN CAN BE ATTRIBUTED TO A MISALIGNMENT BETWEEN THE POWER PORT AND BATTERY OUTPUT CONNECTOR. AN INTERNAL INVESTIGATION WAS OPENED TO INVESTIGATE BENT/DAMAGED PINS WITH CONTROLLER 2.0. FAILURE ANALYSIS OF THE RETURNED PUMP DID NOT REVEAL ANY ABNORMALITIES. LOG FILE ANALYSIS REVEALED FOUR CONTROLLER POWER-UPS WITH THEIR ASSOCIATED MOTOR STARTS LOGGED SINCE 05-AUG-2018. NO ANOMALIES WERE OBSERVED DURING THE RECORDED CONTROLLER POWER-UPS. THE FINAL CONTROLLER POWER-UP WAS LOGGED ON 16-AUG-2018 AT 15:22:05. THE DATA POINT PRIOR TO THE CONTROLLER POWER UP, LOGGED ON THE CONTROLLER'S INTERNAL LOGS ON 12-AUG-2018 AT 07:40:04, REVEALED THAT BAT551508 WAS CONNECTED TO POWER PORT 1 WITH 98%RELATIVE STATE OF CHARGE (RSOC) AND BAT551216 WAS CONNECTED TO POWER PORT 2 WITH 90% RSOC. THE DATA POINT AFTER THE CONTROLLER POWER UP EVENT, LOGGED ON 16-AUG-2018 AT 15:22:41, REVEALED THAT BAT551246 WAS CONNECTED TO POWER PORT 1 AND NO POWER SOURCE WAS CONNECTED TO POWER PORT 2. THE CONTROLLER WAS WITHOUT POWER FOR 4 DAYS, 7 HOURS, 40 MINUTES, AND 16 SECONDS. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES FROM THE CONTROLLER. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. IN THIS CASE, THE PATIENT HAD A HISTORY OF PREVIOUS SUICIDE ATTEMPTS. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: MODEL #: SERIAL OR LOT#: CON308662 H3: YES DEV RTN TO MFR? YES H5: NO H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3243 H6: FDA CONCLUSION CODE(S): 19, 4315 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS FURTHER REPORTED THAT THE CONTROLLER AC ADAPTER WAS TIGHTLY STRETCHED THROUGH SOME BEDDING AND UNDER THE MATTRESS AND AROUND THE BEDSIDE TABLE, BUT THE PRONGS WERE NOT FULLY PLUGGED INTO THE ELECTRICAL STRIP. IT WAS BELIEVED THAT THE CONTROLLER THEN HAD A ¿NO POWER SOURCE CONNECTED ALARM¿ AND THE PATIENT BENT THE CONTROLLER POWER PORT PINS WHEN THEY ATTEMPTED TO CONNECT A BATTERY.
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 / (B)(4)/ MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 2018-07-31 UDI #: (B)(4), RETURN DATE: 2018-08-23, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-07-31. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
NO EVAL OTHER DESCRIPTION: ANALYSIS CANNOT BE COMPLETED AT THIS TIME DUE TO PENDING LITIGATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE DATE AND CAUSE OF DEATH. DATE OF DEATH WAS UPDATED FROM 13-AUG-2018 TO 14-AUG-2018. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. THE CAUSE OF DEATH WAS COLLECTED DURING A REVIEW OF PATIENT RECORDS WITH THE HEALTHCARE FACILITY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD AT HOME AND IS PRESUMED TO HAVE EXPIRED APPROXIMATELY THREE DAYS EARLIER. IT WAS REPORTED THAT THE CONTROLLER LOST POWER AND THE PUMP STOPPED. THE CAUSE OF DEATH IS UNKNOWN.
IT WAS FURTHER REPORTED THAT THE CAUSE OF DEATH WAS RELATED TO AN ACCIDENTAL CONTROLLER DISCONNECT. THE CAUSE OF DEATH WAS COLLECTED DURING A REVIEW OF PATIENT RECORDS WITH THE HEALTHCARE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660008 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707000017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male | Death |