HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
Report
- Report Number
- 3007042319-2020-03306
- Event Type
- Injury
- Date Received
- May 22, 2020
- Date of Event
- April 1, 2020
- Report Date
- November 25, 2020
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707003261
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H10 A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION AND CORRECTIONS. NEWLY RECEIVED INFORMATION INDICATED THAT THE VENTRICULAR ASSIST DEVICE EXHIBITED CONTINUED HIGH WATT ALARMS AND THE PATIENT WAS BEING WORKED UP FOR A TRANSPLANT. B2 OUTCOME ATTRIBUTED TO ADVERSE EVENT CORRECTED FROM HOSPITALIZATION TO LIFE THREATENING, INTERVENTION REQUIRED, HOSPITALIZATION. B3 DATE OF EVENT CORRECTED FROM (B)(6) 2020 TO (B)(6) 2020. B5 DESCRIPTION OF EVENT PROBLEM CORRECTED TO INCLUDE THAT THE PATIENT WAS ASYMPTOMATIC AND FELT WELL, AND THE OUTFLOW GRAFT (OFG) WAS SUSPECTED TO HAVE BUILD-UP BETWEEN THE OFG AND THE GORE-TEX. BLOOD CULTURES WERE POSITIVE FOR YEAST OF AN UNKNOWN SOURCE AND THE PATIENT RECEIVED ANTIFUNGALS. THE OFG REMAINS IN USE. B7 RELEVANT HISTORY CORRECTED FROM NON-ISCHEMIC CARDIOMYOPATHY, VENTRICULAR ASSIST DEVICE (VAD) TO NON-ISCHEMIC CARDIOMYOPATHY, LEFT VENTRICULAR ASSIST DEVICE. D11 CONCOMITANT PRODUCT CORRECTED TO DVBB1D1 ICD; 693565 LEAD IMPLANTED (B)(6) 2014. E1 INITIAL REPORTER FACILITY NAME CORRECTED FROM (B)(6) HOSPITAL TO (B)(6) HOSPITAL AND PHONE NUMBER CORRECTED TO (B)(6). E3 INITIAL REPORTER OCCUPATION CORRECTED TO OTHER HEALTHCARE PROFESSIONAL (OTHER). G3 REPORT SOURCE CORRECTED FROM HEALTH PROFESSIONAL TO HEALTH PROFESSIONAL, COMPANY REPRESENTATIVE. H6 PATIENT CODES CORRECTED FROM C3245 TO C26726. H10 CORRECTED TO INCLUDE ADDITIONAL PRODUCT. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ OUTFLOW GRAFT D4: MODEL #: 1125 / CATALOG #: 1125 / EXPIRATION DATE: 31-AUG-2023 / LOT #: 17469998-1413. UDI #: (B)(4). D10: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. H4: MFG DATE: 01-AUG-2018. H5: NO. H6: PATIENT CODE(S): C26726. H6: DEVICE CODE(S): C63287. H6: FDA RESULTS CODE(S): 3233. H6: FDA CONCLUSION CODE(S): 11. 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 SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE STERILITY CERTIFICATE CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED LOW FLOW EVENT WAS CONFIRMED THROUGH LOG FILE ANALYSIS WHICH REVEALED A SLIGHT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON (B)(6) 2020 AND A SUBSEQUENT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON (B)(6) 2020; 55 LOW FLOW ALARMS WERE RECORDED SINCE (B)(6) 2020. OF NOTE, IT WAS REPORTED THAT AN ADDITIONAL SURROUNDING GRAFT HAD BEEN PLACED AROUND THE OUTFLOW GRAFT BY THE SURGEON AT IMPLANT AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN SUGGESTED BUILDUP BETWEEN THE GRAFTS. HOWEVER, THE REPORTED OUTFLOW GRAFT COMPRESSION EVENT COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO CONSTRICTION AT THE OUTFLOW GRAFT, THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, AND/OR POOR VAD FILLING. 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. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) AND THE ASSOCIATED OUTFLOW GRAFT WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE PUMP'S STERILITY CERTIFICATE CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED LOW FLOW EVENT WAS CONFIRMED THROUGH LOG FILE ANALYSIS WHICH REVEALED A SLIGHT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON (B)(6) 2020 AND A SUBSEQUENT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON (B)(6) 2020; 55 LOW FLOW ALARMS WERE RECORDED SINCE (B)(6) 2020. NO HIGH WATT ALARMS WERE LOGGED WITHIN THE ANALYZED PERIOD. THE AVAILABLE LOG FILES COVERED THE PERIOD THROUGH (B)(6) 2020; AS A RESULT, THE REPORTED HIGH WATT ALARM EVENT REPORTED ON (B)(6) 2020 COULD NOT BE CONFIRMED. OF NOTE, IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A FILLING DEFICIT ON THE OUTFLOW GRAFT, LIKELY DUE TO BUILDUP BETWEEN THE OUTFLOW GRAFT AND AN ADDITIONAL SURROUNDING GRAFT THAT HAD BEEN PLACED AROUND THE OUTFLOW GRAFT BY THE SURGEON AT IMPLANT. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE CAUSE OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED, BUT NOT LIMITED, TO CONSTRICTION OF THE OUTFLOW GRAFT DUE TO MATERIAL BETWEEN THE OUTFLOW GRAFT AND THE FOREIGN GRAFT. BASED ON THE RISK DOCUMENTATION, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED HIGH WATT ALARM EVENT INCLUDING, BUT NOT LIMITED TO, THROMBUS FORMATION/INGESTION, HIGH FLOWS, AND/OR INCORRECT SETTING OF THE ALARM THRESHOLD. 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: LOT #: 17469998-1413. H3: YES. H6: FDA METHOD CODE(S): 4114 H6: FDA RESULTS CODE(S): 3221 H6: FDA CONCLUSION CODE(S): 22, 67 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. THE DEVICES WERE RETURNED AND INVESTIGATION WAS COMPLETED. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) AND THE ASSOCIATED OUTFLOW GRAFT WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. REVIEW OF THE PUMP'S STERILITY CERTIFICATE CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION, FUNCTIONAL TESTING, AND DIMENSIONAL VERIFICATION. FAILURE ANALYSIS OF THE RETURNED OUTFLOW GRAFT SEGMENTS REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION. INTERNAL PATHOLOGICAL REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE DEVICES. THE REPORTED LOW FLOW EVENT WAS CONFIRMED THROUGH LOG FILE ANALYSIS WHICH REVEALED A SLIGHT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON 04-APR-2020 AND A SUBSEQUENT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON 23-APR-2020; 55 LOW FLOW ALARMS WERE RECORDED SINCE 28-APR-2020. NO HIGH WATT ALARMS WERE LOGGED WITHIN THE ANALYZED PERIOD. THE AVAILABLE LOG FILES COVERED THE PERIOD THROUGH 30-APR-2020; AS A RESULT, THE REPORTED HIGH WATT ALARM EVENT REPORTED ON 17-JUL-2020 COULD NOT BE CONFIRMED. OF NOTE, IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A FILLING DEFICIT ON THE OUTFLOW GRAFT, LIKELY DUE TO BUILDUP BETWEEN THE OUTFLOW GRAFT AND AN ADDITIONAL SURROUNDING GRAFT THAT HAD BEEN PLACED AROUND THE OUTFLOW GRAFT BY THE SURGEON AT IMPLANT. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT'S BLOOD CULTURES WERE POSITIVE FOR YEAST OF AN UNKNOWN SOURCE AND THE PATIENT RECEIVED ANTIFUNGALS. PER THE INSTRUCTIONS FOR USE, INFECTION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF INFECTION EVENTS. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE CAUSE OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED, BUT NOT LIMITED, TO CONSTRICTION OF THE OUTFLOW GRAFT DUE TO MATERIAL BETWEEN THE OUTFLOW GRAFT AND THE FOREIGN GRAFT. BASED ON THE RISK DOCUMENTATION, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED HIGH WATT ALARM EVENT INCLUDING, BUT NOT LIMITED TO, THROMBUS FORMATION-INGESTION, HIGH FLOWS, AND-OR INCORRECT SETTING OF THE ALARM THRESHOLD. 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: LOT #: 17469998-1413 D9: YES, RETURN DATE: 05-OCT-2020 DEV RTN TO MFR? YES H6: PATIENT IME CODE(S): E1906 H6: IMF CODE(S): F1203, F08, F22, F2203, F2303 H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 213 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 A CORRECTION TO INCLUDE LAB VALUE IN B6 AND AN UPDATE FOR TRANSPLANT IN B5. 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.
IT WAS FURTHER REPORTED THAT THE VENTRICULAR ASSIST DEVICE EXHIBITED CONTINUED HIGH WATT ALARMS AND THE PATIENT WAS BEING WORKED UP FOR A TRANSPLANT. IT WAS ALSO REPORTED THAT THE PATIENT WAS ASYMPTOMATIC AND FELT WELL, AND THE OUTFLOW GRAFT (OFG) WAS SUSPECTED TO HAVE BUILD-UP BETWEEN THE OFG AND THE GORE-TEX. BLOOD CULTURES WERE POSITIVE FOR YEAST OF AN UNKNOWN SOURCE AND THE PATIENT RECEIVED ANTIFUNGALS. THE OFG REMAINS IN USE.
IT WAS FURTHER REPORTED THAT THE PATIENT WAS TRANSPLANTED.
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. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO LOW FLOWS. PATIENT HAS BEEN EXPERIENCING LOW FLOWS FOR SOME TIME, WITH FLOWS DROPPING FROM 3.0-3.5 TO 2.2-2.5 IN RECENT DAYS. THE PATIENT LATER DEVELOPED A POSITIVE CULTURE FOR YEAST AND IS CURRENTLY BEING TREATED. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A FILING DEFICIT ON THE OUTFLOW GRAFT DUE TO BUILDUP, HOWEVER NO ISSUES WITH INFLOW CANNULA. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 547228 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707003261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization| L| R | DVBB1D1 ICD, 693565 LEAD |