HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2020-05900
- Event Type
- Injury
- Date Received
- September 30, 2020
- Date of Event
- September 22, 2020
- Report Date
- May 9, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-201
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR AN UPDATE TO THE DEVICE EVALUATION AND INVESTIGATION. PRODUCT EVENT SUMMARY: THE PUMP (B)(6) WAS NOT RETURNED FOR EVALUATION. ONE (1) CONTROLLER (B)(6) AND SIX (6) BATTERIES (B)(6) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6). LOG FILE ANALYSIS ALSO REVEALED SEVERAL INTERMITTENT DECREASES IN POWER CONSUMPTION AND ESTIMATED FLOWS FOR THE PAST 14 DAYS LEADING UP TO (B)(6) 2020. 55 LOW FLOW ALARMS WERE LOGGED SINCE (B)(6) 2020 AND 1 HIGH WATT ALARM ACCOMPANIED WITH INCREASES IN PUMP ROTATIONAL SPEED WAS LOGGED ON (B)(6) 2020. AS A RESULT, THE REPORTED PREMATURE POWER SWITCHING, LOW FLOW, AND HIGH WATT ALARM EVENT WAS CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE ASSOCIATED BATTERIES. INFORMATION PROVIDED BY THE SITE INDICATED THAT THE PATIENT EXPERIENCED LOW FLOWS OVERNIGHT. THE LOW FLOWS WERE RELATED TO PATIENT CONDITION OF HYPOVOLEMIA AND TACHYCARDIA AT NIGHT. THE PATIENT WAS TREATED ON AN OUTPATIENT BASIS AND WAS ADVISED TO DRINK MORE FLUIDS. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LOW FLOW EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. CAPA PR00389403 INVESTIGATED MOMENTARY DISCONNECTIONS. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) AND THE ASSOCIATED BATTERIES FALL WITHIN THE BOUNDS OF THIS CAPA. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, AND/OR PATIENT RELATED FACTORS. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE HIGH WATT ALARM EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION, INAPPROPRIATE PUMP ROTATIONAL SPEED, AND/OR PATIENT RELATED FACTORS. PER THE INSTRUCTIONS FOR USE, CARDIAC ARRHYTHMIA IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF 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. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ PUMP D4: SERIAL#: (B)(6), H3: YES, H6: FDA METHOD CODE(S): B15, B17, H6: FDA RESULTS CODE(S): C19, H6: FDA CONCLUSION CODE(S): D12 THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER D00595825 DUE TO AN FDA AUDIT OBSERVATION. 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.
THIS SUPPLEMENTAL IS BEING SUBMITTED FOR COMPLETED ANALYSIS AND INVESTIGATION. PRODUCT EVENT SUMMARY: THE CONTROLLER AND SIX (6) BATTERIES WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE ASSOCIATED BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. CAPA PR00389403 INVESTIGATED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: (B)(6) H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 (B)(6) H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 (B)(6) H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 (B)(6) H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 (B)(6) H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 (B)(6) H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): 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 REPORT IS BEING SUBMITTED FOR CORRECTION AND UPDATE TO THE INVESTIGATION. CORRECTION B1: ADVERSE EVENT OR PRODUCT PROBLEM WAS CORRECTED FROM PRODUCT PROBLEM TO ADVERSE EVENT PRODUCT PROBLEM. CORRECTION B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS CORRECTED FROM BLANK TO INTERVENTION REQUIRED. CORRECTION B5: EVENT DESCRIPTION WAS CORRECTED TO INCLUDE THE VENTRICULAR ASSIST DEVICE (VAD) AS AN ASSOCIATED DEVICE AND PATIENT SI GNS/SYMPTOMS. CORRECTION H1: TYPE OF REPORTABLE EVENT WAS CORRECTED FROM MALFUNCTION TO SERIOUS INJURY. CORRECTION H6: PATIENT IME CODE WAS CORRECTED FROM E2403 TO E0305, E060109. PATIENT IMF CODE WAS CORRECTED FROM F26 TO F12, F23. CORRECTION H10: ADDITIONAL MANUFACTURER NARRATIVE WAS CORRECTED TO INCLUDE THE VAD AS AN ADDITIONAL PRODUCT RELATED TO THE REPORTED EVENT. ADDITIONAL PRODUCTS: (B)(6) H6: PATIENT IME CODE(S): E0305, E060109 H6: IMF CODE(S): F12, F23 H6: IMG CODE(S): G02002 (B)(6) H6: PATIENT IME CODE(S): E0305, E060109 H6: IMF CODE(S): F12, F23 H6: IMG CODE(S): G02002 (B)(6) H6: PATIENT IME CODE(S): E0305, E060109 H6: IMF CODE(S): F12, F23 H6: IMG CODE(S): G02002 (B)(6) H6: PATIENT IME CODE(S): E0305, E060109 H6: IMF CODE(S): F12, F23 H6: IMG CODE(S): G02002 (B)(6) H6: PATIENT IME CODE(S): E0305, E060109 H6: IMF CODE(S): F12, F23 H6: IMG CODE(S): G02002 (B)(6) H6: PATIENT IME CODE(S): E0305, E060109 H6: IMF CODE(S): F12, F23 H6: IMG CODE(S): G02002 ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ PUMP D4: MODEL #: 1104 / CATALOG #: 1104 / EXPIRATION DATE: UNK / SERIAL OR LOT#: (B)(6) UDI #: (B)(4) D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: UNK H5: YES H6: PATIENT IME CODE(S): E0305, E060109 H6: IMF CODE(S): F12, F23 H6: IMG CODE(S): G04105 H6: FDA DEVICE CODE(S): A1412 H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16 THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER (B)(4) DUE TO AN FDA AUDIT OBSERVATION. 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.
IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED LOW FLOW ALARMS AND BATTERY SWITCHING OVERNIGHT. REVIEW OF LOGFILES SHOWED MULTIPLE LOW FLOW ALARMS AND A HIGH WATT ALARM EIGHTEEN (18) DAYS PRIOR. IT WAS ASSUMED THAT THE VENTRICULAR ASSIST DEVICE (VAD) LOW FLOWS WERE RELATED TO PATIENT CONDITION OF HYPOVOLEMIA AND TACHYCARDIA AT NIGHT. THE PATIENT WAS TREATED ON AN OUTPATIENT BASIS AND WAS ADVISED TO DRINK MORE FLUIDS. THE VAD REMAINS IN USE.
ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-MAR-2021 / SERIAL #: (B)(4), UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/THERAPY DATES? NO. MFG DATE: 07-MAR-2020. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2019 / SERIAL #: (B)(4), UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/THERAPY DATES? NO. MFG DATE: 06-DEC-2018. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2019 / SERIAL #: (B)(4), UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/THERAPY DATES? NO. MFG DATE: 06-DEC-2018. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-OCT-2020 / SERIAL #: (B)(4), UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/THERAPY DATES? NO. MFG DATE: 19-OCT-2019. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2019 / SERIAL #: (B)(4), UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/THERAPY DATES? NO. MFG DATE: 06-DEC-2018. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2019 / SERIAL #: (B)(4), UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/THERAPY DATES? NO. MFG DATE: 06-DEC-2018. LABELED FOR SINGLE USE? NO. (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE EVENT, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE SENT. 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 CONTROLLER AND BATTERIES EXHIBITED POWER SWITCHING. THE CONTROLLER AND BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1074599 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention | (B)(6) VAD.| 1104 VAD |