HEARTWARE VENTRICULAR ASSIST SYSTEM-OUTFLOW GRAFT
Report
- Report Number
- 3007042319-2019-07094
- Event Type
- Injury
- Date Received
- May 28, 2019
- Date of Event
- May 1, 2019
- Report Date
- September 16, 2024
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000222
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL IS BASED SOLELY ON THE RECEIPT OF A 3500A REPORT. SECTION F HAS BEEN UPDATED TO REFLECT THAT REPORT. F1 USER FACILITY F2 UF/IMPORTER REPORT NUMBER: (B)(4). F3 USER FACILITY NAME/ADDRESS (B)(6). F4 CONTACT PERSON: (B)(6). F5 PHONE NUMBER: (B)(6). F6 DATE USER FACILITY BECAME AWARE OF EVENT: UNKNOWN. F7 TYPE OF REPORT: INITIAL. F8 DATE OF THIS REPORT: APR-2020. F9 APPROXIMATE AGE OF DEVICE: 5 YEARS. F12 LOCATION WHERE EVENT OCCURRED: HOME. F13 REPORT SENT TO MANUFACTURER: YES, APR-2020. F14 MANUFACTURER NAME AND ADDRESS MFR. NAME: HEARTWARE INC. ADDL: 14400 NW 60TH AVE CITY: MIAMI LAKES STATE: FL ZIP: 33014. 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. 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.
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 EVALUATION. PRODUCT EVENT SUMMARY: THE OUTFLOW GRAFT WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS CONFIRMED THROUGH LOG FILE ANALYSIS WHICH REVEALED A SLIGHT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOW STARTING ON (B)(6) 2019 AND 209 LOW FLOW ALARMS LOGGED SINCE (B)(6) 2019. ADDITIONALLY, ONE HIGH WATT ALARM WAS LOGGED ON (B)(6) 2019 FOLLOWING AN INCREASE IN VENTRICULAR ASSIST DEVICE (VAD) ROTATIONAL SPEED. OF NOTE, IT WAS REPORTED THAT A CLOT HAD FORMED IN THE AREA BETWEEN THE OUTFLOW GRAFT AND AN ADDITIONAL SURROUNDING GRAFT PLACED BY THE SURGEON AT IMPLANT AND A PROCEDURE WAS PERFORMED TO REMOVE THE SURROUNDING GRAFT, AFTER WHICH FLOW RETURNED TO NORMAL. ADDITIONALLY, A COMPUTERIZED TOMOGRAPHY SCAN REVEALED STENOSIS OF THE OUTFLOW GRAFT AND, DURING AN OPERATION, A COMPRESSION OF THE OUTFLOW GRAFT WAS OBSERVED, AT WHICH POINT THE OUTFLOW GRAFT WAS REPOSITIONED AND THE ALARMS RESOLVED. IT WAS REPORTED THAT THE PATIENT'S WEIGHT GAIN LIKELY CONTRIBUTED TO THIS COMPRESSION. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOW FLOW EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO CONSTRICTION OF THE OUTFLOW GRAFT, WHICH MAY BE DUE TO MATERIAL BETWEEN THE OUTFLOW GRAFT AND THE FOREIGN GRAFT AND/OR DUE TO ANATOMICAL CHANGES RELATED TO THE PATIENT'S WEIGHT GAIN. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE HIGH WATT ALARM EVENT CAN BE ATTRIBUTED TO INAPPROPRIATE VAD ROTATIONAL SPEED AND/OR INCORRECT SETTING OF THE ALARM THRESHOLD. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INC LUDE 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. 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 CORRECTIONS TO B3. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS THE CODES AND INVESTIGATION SUMMARY WAS REVISED. PRODUCT EVENT SUMMARY: THE OUTFLOW GRAFT (LOT 1001921779) WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS WERE NOT PERFORMED AS THE REPORTED EVENT AND ANALYSIS ARE NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE. LOG FILE ANALYSIS REVEALED A SLIGHT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOW STARTING ON (B)(6) 2019, LEADING TO PARAMETERS BELOW NORMAL OPERATING RANGE, AND 209 LOW FLOW ALARMS LOGGED SINCE (B)(6) 2019. ADDITIONALLY, ONE (1) HIGH WATT ALARM WAS LOGGED ON (B)(6) 2019 FOLLOWING AN INCREASE IN PUMP ROTATIONAL SPEED. AS A RESULT, THE REPORTED LOW FLOW EVENT WAS CONFIRMED; HOWEVER, THE REPORTED OUTFLOW GRAFT COMPRESSION COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOW FLOW EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO CONSTRICTION OF THE OUTFLOW GRAFT, WHICH MAY BE DUE TO MATERIAL BETWEEN THE OUTFLOW GRAFT AND THE FOREIGN GRAFT AND/OR DUE TO ANATOMICAL CHANGES RELATED TO THE PATIENT'S WEIGHT GAIN. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE H IGH WATT ALARM EVENT CAN BE ATTRIBUTED TO INAPPROPRIATE PUMP ROTATIONAL SPEED AND/OR INCORRECT SETTING OF THE ALARM THRESHOLD. PER THE INSTRUCTIONS FOR USE, THROMBUS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD SIMILAR ADVERSE EVENTS. 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
PRODUCT EVENT SUMMARY: THE OUTFLOW GRAFT WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS CONFIRMED THROUGH LOG FILE ANALYSIS WHICH REVEALED 108 LOW FLOW ALARMS THAT WERE RECORDED ON (B)(6) 2019. OF NOTE, IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERVENTION FOR THE REMOVAL OF GORE TEX AFTER WHICH THE POWER AND FLOW RETURNED TO NORMAL OPERATING RANGE. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, THE MOST LIKELY ROOT CAUSE OF THE LOW FLOW EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, INAPPROPRIATE PUMP ROTATIONAL SPEED. 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. 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 A COMPUTERIZED TOMOGRAPHY SCAN IDENTIFIED "EXTENSIVE FOCAL FILLING DEFECT AT THE DISTAL END OF THE OUTFLOW CANNULA AT DISTAL ANASTOMOSIS ASSOCIATED WITH SEVERE GREATER THAN 75% LUMINAL STENOSIS." A THROMBUS WAS SUSPECTED DESPITE LACTATE DEHYDROGENASE LEVELS OF 248 UNITS PER LITER. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE INTRAOPERATIVE FINDINGS REVEALED COMPRESSION OF THE OUTFLOW GRAFT (OFG). IT WAS ALSO REPORTED THAT THE PATIENT GAINED 100 POUNDS SINCE IMPLANT AND THIS WAS SUSPECTED TO HAVE CONTRIBUTED TO THE OUTFLOW COMPRESSION. REPOSITIONING OF THE OFG RESOLVED THE ALARMS. THE PATIENT REMAINED STABLE AND WAS DISCHARGED HOME.
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOWS DUE TO A CLOT FORMATION BETWEEN THE OUTFLOW GRAFT AND GORE-TEX THAT HAD BEEN WRAPPED AROUND THE GRAFT DURING IMPLANT. THE GORE-TEX WAS REMOVED AND VAD FLOWS RETURNED TO THE EXPECTED RANGE. THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOWS DUE TO A CLOT FORMATION BETWEEN THE OUTFLOW GRAFT AND GORE-TEX THAT HAD BEEN WRAPPED AROUND THE GRAFT DURING IMPLANT. THE GORE-TEX WAS REMOVED AND VAD FLOWS RETURNED TO THE EXPECTED RANGE. THE 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 |
|---|---|---|---|---|---|---|---|
| 438512 | HEARTWARE VENTRICULAR ASSIST SYSTEM-OUTFLOW GRAFT | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1125 | 1001921779 | 00888707000222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Life Threatening| H| R | 1103 VAD |