HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
Report
- Report Number
- 3007042319-2023-01142
- Event Type
- Death
- Date Received
- March 8, 2023
- Date of Event
- February 1, 2023
- Report Date
- May 8, 2023
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION: A5B, B5,B7, H6, ADDITIONAL CODES AND ADDITIONAL PRODUCTS: ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ OUTFLOW GRAFT H6: PATIENT IME CODE(S): E0102, E0103, E0118, E0140, E0301 AND E233601 H6: IMF CODE(S): F22 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE PUMP ((B)(6)) AND THE ASSOCIATED OUTFLOW GRAFT (LOT NO. 368899-8229) WERE NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS CONFIRMED VIA LOG FILE ANALYSIS WHICH REVEALED 74 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2023. INFORMATION PROVIDED BY THE SITE INDICATED THE PATIENT HAD SYMPTOMS FOR APPROXIMATELY ONE MONTH AND WAS THEN ADMITTED TO THE HOSPITAL FOR A SUSPECTED STROKE AND EXPERIENCED LEFT SIDED WEAKNESS. THE PATIENT HAD BEEN ¿FALLING AT TIMES,¿ WERE UNABLE TO GRAB WITH THEIR LEFT HAND, AND HAD A SHARP PAIN AT TIMES FROM THEIR MID BACK DOWN THEIR LEFT LEG. IT WAS FURTHER REPORTED THAT THE VAD DRIVELINE DRAINAGE WORSENED WHICH SOAKED THE DRESSING. THE PATIENT ALSO REPORTED ¿TINGLING AT TIMES¿ AND THEIR LEFT LEG BUCKLING UNDER THEM. THEY ALSO REPORTED FEELING ANXIETY AND WERE ON ANTIDEPRESSANTS. A COMPUTERIZED TOMOGRAPHY (CT) AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) FOR THE HEAD AND NECK WERE NEGATIVE BUT SHOWED AN EXTENSIVE OUTFLOW GRAFT OCCLUSION. THE PATIENT HAD DECREASED GRIPS IN THEIR LEFT UPPER EXTREMITIES BUT COULD HOLD UP THEIR ARMS. THE PATIENT ALSO HAD AN ONGOING DRY COUGH WITHOUT SPUTUM PRODUCTION. THE PATIENT¿S INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.8 WITH A GOAL OF 2-3, BUT THEY HAVE NOT BEEN ¿COMPLETELY¿ COMPLIANT WITH THEIR ANTICOAGULATION. IN ADDITION, HOSPICE WAS CONSIDERED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A HERNIATED STROKE, WAS INTUBATED AND WENT INTO VENTRICULAR TACHYCARDIA (VT). THE PATIENT'S SUPPORT WAS THEN WITHDRAWN AND THEY SUBSEQUENTLY EXPIRED. THE OUTFLOW GRAFT OBSTRUCTION WAS TREATED WITH A STENT WHILE UNDERGOING A RIGHT HEART CATHETERIZATION ON DAY EIGHT (8) OF THE ADMISSION AND VENTRICULAR TACHYCARDIA (VT) EVENTS WERE OBSERVED DURING STENT PLACEMENT AND TREATED WITH MEDICATION. ANEMIA, WHICH IS CHRONIC FOR THE PATIENT, WAS ALSO NOTED DURING THE ADMISSION AND WAS TREATED WITH IRON SUPPLEMENTS. THE PATIENT CONTINUED TO DECLINE AND DEVELOPED CARDIOGENIC SHOCK AND ON DAY NINE (9) OF THE ADMISSION THE PATIENT HAD AN ACUTE SUBARACHNOID HEMORRHAGE (SAH) WHICH PROGRESSED OVER SEVENTY-TWO HOURS TO BECOME MULTIFOCAL HEMORRHAGES DESPITE CESSATION OF ALL ANTICOAGULANTS AND ANTIPLATELET MEDICATIONS. RUNS OF VT WERE NOTED OVERNIGHT ON DAY ELEVEN (11) OF THE ADMISSION BUT SPONTANEOUSLY RESOLVED. A CEREBRAL ANGIOGRAM WAS DONE DUE TO HISTORY OF CHRONIC DRIVELINE INFECTION AND WORSENING DRIVELINE DRAINAGE (WHICH WAS TREATED WITH INTRAVENOUS ANTIBIOTICS DURING THE ADMISSION), ON DAY TWELVE (12) OF THE ADMISSION WHICH WAS NEGATIVE FOR A MYCOTIC ANEURYSM OR EVIDENCE OF INFECTIOUS PROCESS. THE PATIENT'S CONDITION CONTINUED TO FURTHER DECLINE WITH INCREASED INTRACRANIAL PRESSURE PROGRESSING TO A BRAIN HERNIATION AND CEREBRAL EDEMA AND THE PATIENT WAS REMOVED FROM SUPPORT AND EXPIRED ON DAY FOURTEEN (14) OF THE ADMISSION. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE 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, THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR POOR VAD FILLING. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBUS, NEUROLOGICAL DYSFUNCTION, CARDIAC ARRHYTHMIA, AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. BASED ON A REVIEW OF PAST ADVERSE EVENTS, IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF THROMBUS, CARDIAC ARRHYTHMIA EVENTS. POSSIBLE FACTORS THAT MAY HAVE LED TO THIS EVENT INCLUDE, BUT ARE NOT LIMITED TO, THE PATIENT¿S NON-COMPLIANCE OR OTHER ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS, THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, 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: OUTFLOW GRAFT D4: LOT#: 368899-8229 H3: YES H6: FDA METHOD CODE(S): B17 H6: FDA RESULTS CODE(S): C20 H6: FDA CONCLUSION CODE(S): D12 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 ADDITIONAL EVENT DETAILS. 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.
ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING 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. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ OUTFLOW GRAFT, MODEL #: 1125/ CATALOG #: 1125/ EXPIRATION DATE: 31-OCT-2020/ SERIAL OR LOT#: 368899-8229 UDI #: (B)(4), DEVICE AVAILABLE FOR MANUFACTURER EVALUATION: NO. DEVICE LABELED FOR SINGLE USE: NO. ADVERSE EVENT PROBLEM: PATIENT IME CODE(S): E0514, E0712, E0133, E1621, E013403, E020201, E2007, E2315, E2328, E2330; IMF CODE(S): F08, F1203, F2203 ; IMG CODE(S): G04019; FDA DEVICE CODE(S): A1409; FDA METHOD CODE(S): B21; FDA RESULTS CODE(S): C21; 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. 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 OUTFLOW GRAFT OBSTRUCTION WAS TREATED WITH A STENT WHILE UNDERGOING A RIGHT HEART CATHETERIZATION ON DAY EIGHT (8) OF THE ADMISSION AND VENTRICULAR TACHYCARDIA (VT) EVENTS WERE OBSERVED DURING STENT PLACEMENT AND TREATED WITH MEDICATION. ANEMIA, WHICH IS CHRONIC FOR THE PATIENT, WAS ALSO NOTED DURING THE ADMISSION AND WAS TREATED WITH IRON SUPPLEMENTS. THE PATIENT CONTINUED TO DECLINE AND DEVELOPED CARDIOGENIC SHOCK AND ON DAY NINE (9) OF THE ADMISSION THE PATIENT HAD AN ACUTE SUBARACHNOID HEMORRHAGE (SAH) WHICH PROGRESSED OVER SEVENTY-TWO HOURS TO BECOME MULTIFOCAL HEMORRHAGES DESPITE CESSATION OF ALL ANTICOAGULANTS AND ANTIPLATELET MEDICATIONS. RUNS OF VT WERE NOTED OVERNIGHT ON DAY ELEVEN (11) OF THE ADMISSION BUT SPONTANEOUSLY RESOLVED. A CEREBRAL ANGIOGRAM WAS DONE DUE TO HISTORY OF CHRONIC DRIVELINE INFECTION AND WORSENING DRIVELINE DRAINAGE (WHICH WAS TREATED WITH INTRAVENOUS ANTIBIOTICS DURING THE ADMISSION), ON DAY TWELVE (12) OF THE ADMISSION WHICH WAS NEGATIVE FOR A MYCOTIC ANEURYSM OR EVIDENCE OF INFECTIOUS PROCESS. THE PATIENT'S CONDITION CONTINUED TO FURTHER DECLINE WITH INCREASED INTRACRANIAL PRESSURE PROGRESSING TO A BRAIN HERNIATION AND CEREBRAL EDEMA AND THE PATIENT WAS REMOVED FROM SUPPORT AND EXPIRED ON DAY FOURTEEN (14) OF THE ADMISSION.
IT WAS FURTHER REPORTED THAT THE PATIENT HAD A HERNIATED STROKE, WAS INTUBATED AND WENT INTO VENTRICULAR TACHYCARDIA (VT). THE PATIENT'S SUPPORT WAS WITHDRAWN AND THEY SUBSEQUENTLY EXPIRED.
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT HAD SYMPTOMS FOR APPROXIMATELY ONE MONTH AND THEN WAS ADMITTED TO THE HOSPITAL FOR A SUSPECTED STROKE AND HAD LEFT SIDED WEAKNESS. THEY HAD BEEN ¿FALLING AT TIMES,¿ WERE UNABLE TO GRAB WITH THEIR LEFT HAND AND HAD A SHARP PAIN AT TIMES FROM THEIR MID BACK DOWN THEIR LEFT LEG. IT WAS FURTHER REPORTED THAT THE VAD DRIVELINE DRAINAGE WORSENED WHICH SOAKED THE DRESSING. THE PATIENT ALSO REPORTED ¿TINGLING AT TIMES¿ AND THEIR LEFT LEG BUCKLING UNDER THEM. THEY ALSO REPORTED FEELING ANXIETY AND WERE ON ANTIDEPRESSANTS. A COMPUTERIZED TOMOGRAPHY (CT) AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) FOR THE HEAD AND NECK WERE NEGATIVE, BUT SHOWED AN EXTENSIVE OUTFLOW GRAFT OCCLUSION. THE PATIENT HAD DECREASED GRIPS IN THEIR LEFT UPPER EXTREMITIES BUT COULD HOLD UP THEIR ARMS. THE PATIENT ALSO HAD AN ONGOING DRY COUGH WITHOUT SPUTUM PRODUCTION AND THE VAD EXHIBITED LOW FLOW ALARMS. THE PATIENT¿S INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.8 WITH A GOAL OF 2-3, BUT THEY HAVE NOT BEEN ¿COMPLETELY¿ COMPLIANT WITH THEIR ANTICOAGULATION. IT WAS FURTHER REPORTED THAT HOSPICE IS BEING CONSIDERED. 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 |
|---|---|---|---|---|---|---|---|
| 1735617 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Death| H| L |