HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2021-05237
- Event Type
- Injury
- Date Received
- July 6, 2021
- Date of Event
- June 25, 2021
- Report Date
- December 22, 2021
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000420
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1427-2020, Z-1428-2020
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS INVESTIGATION SUMMARY WAS REVISED. PRODUCT EVENT SUMMARY: TWO (2) CONTROLLERS (B)(6) AND FIVE (5) BATTERIES (B)(6) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PRIMARY CONTROLLER, INITIALLY IN USE DURING THE REPORTED EVENT DATE. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER UP EVENTS WITH AN ASSOCIATED PUMP START EVENTS LOGGED ON (B)(6) 2021 AT 15:20:37 AND ON (B)(6) 2021 AT 06:16:23. REVIEW OF THE EVENT LOG FILE REVEALED THAT, PRIOR TO THE FIRST POWER UP EVENT, THE CONTROLLER LAST HAD POWER ON (B)(6) 2020. ADDITIONALLY, REVIEW OF THE DATA LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE FIRST POWER UP EVENT; THE FIRST DATA POINT WAS LOGGED ON (B)(6) 2021 AT 15:21:10, INDICATING THAT THE FIRST POWER UP EVENT OCCURRED DURING A CONTROLLER EXCHANGE. THE DATA POINT RECORDED PRIOR TO THE SECOND LOSS OF POWER REVEALED THAT AN ACTIVE ADAPTER WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 93% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT NO POWER SOURCE WAS CONNECTED TO POWER PORT (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). THE CONTROLLER WAS WITHOUT POWER FOR 25 SECONDS. NO ANOMALIES WERE NOTED LEADING UP TO THE LOSS OF POWER. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) ALSO REVEALED MULTIPLE CONTROLLER POWER UP EVENTS WITH AN INCORRECT DATE STAMP. ANALYSIS OF THE (B)(6)'S ALARM LOG FILE REVEALED MULTIPLE CRITICAL BATTERY ALARMS LOGGED WITH AN INCORRECT DATE STAMP AND NO BATTERY CAPACITY, SERIAL NUMBER ID, OR CYCLE COUNT. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED A CONTROLLER POWER UP EVENT WITH AN ASSOCIATED MOTOR START EVENT LOGGED ON (B)(6) 2021 AT 16:23:57. REVIEW OF THE EVENT LOG FILE REVEALED THAT, PRIOR TO THE POWER UP EVENT, THE CONTROLLER LAST HAD POWER ON (B)(6) 2021. ADDITIONALLY, REVIEW OF THE DATA LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE POWER UP EVENT; THE FIRST DATA POINT WAS LOGGED ON (B)(6) 2021 AT 16:24:31, INDICATING THAT THE POWER UP EVENT OCCURRED DURING A CONTROLLER EXCHANGE. LOG FILE ANALYSIS ALSO REVEALED FOUR (4) ADDITIONAL CONTROLLER POWER UPS WITH ASSOCIATED MOTOR START EVENTS LOGGED ON (B)(6) 2021 AT 15:05:48, 15:06:19, 15:11:28 AND 15:43:24, RESPECTIVELY. THE CONTROLLER WAS WITHOUT POWER FOR 17 SECONDS, 3 MINUTES AND 3 SECONDS, 5 MINUTES AND 50 SECONDS, 30 SECONDS, AND 16 SECONDS, RESPECTIVELY. ANALYSIS OF (B)(6)'S ALARM LOG FILE REVEALED MULTIPLE CRITICAL BATTERY ALARMS LOGGED WITH A BATTERY RELATIVE STATE OF CHARGE (RSOC) VALUE OF 101% LOGGED AND SERIAL NUMBER ID, OR CYCLE COUNT. REVIEW OF (B)(6)'S DATA LOG FILE REVEALED MULTIPLE DATA POINTS WITH A BATTERY RELATIVE STATE OF CHARGE (RSOC) VALUE OF 101% LOGGED WITH NO SERIAL NUMBER IDS OR CYCLE COUNTS, INDICATING THAT THE CONTROLLER WAS UNABLE TO RECOGNIZE THE CONNECTED BATTERIES AND LIKELY TRIGGERING POWER DISCONNECT ALARMS. IT IS LIKELY THE ABNORMAL RSOC VALUES ARE RELATED TO THE REPORTED COMMUNICATION ERROR EVENT. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE INITIAL CONTROLLER POWER UP EVENTS ON BOTH CONTROLLER CAN BE ATTRIBUTED TO CONTROLLER EXCHANGES. A POSSIBLE ROOT CAUSE OF THE REMAINING LOSSES OF POWER ON BOTH CONTROLLERS CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; THE MOST LIKELY ROOT CAUSE OF THE INABILITY OF THE CONTROLLER TO RECOGNIZE THE BATTERIES CAN BE ATTRIBUTED TO DAMAGED INTEGRATED CIRCUITS ON EACH OF THE CONTROLLERS' COMMUNICATION LINES. THE INTEGRATED CIRCUIT IS RESPONSIBLE FOR THE COMMUNICATION BETWEEN CONTROLLER AND BATTERIES AND IS ALSO CONNECTED TO THE REAL TIME CLOCK. THE DAMAGED INTEGRATED CIRCUITS LIKELY PREVENTED THE CONTROLLERS FROM DETERMINING THE CAPACITY OF BATTERIES, THEREFORE TRIGGERING POWER DISCONNECT ALARMS, CRITICAL BATTERY ALARMS AND THE ABNORMAL RSOC VALUES. A POSSIBLE ROOT CAUSE FOR THE DAMAGED INTEGRATED CIRCUITS ON THE COMMUNICATION LINES CAN BE ATTRIBUTED TO VOLTAGE SPIKES ON THE COMMUNICATION PINS OF THE CONNECTORS. CAPA PR00465502 WAS OPENED TO INVESTIGATE THIS ISSUE. 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. NY 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 AND INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: TWO (2) CONTROLLERS ((B)(4) ) AND FIVE (5) BATTERIES ((B)(4) ) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT (B)(4) WAS THE PRIMARY CONTROLLER, INITIALLY IN USE DURING THE REPORTED EVENT DATE. LOG FILE ANALYSIS ASSOCIATED WITH (B)(4) REVEALED TWO (2) CONTROLLER POWER UP EVENTS WITH AN ASSOCIATED PUMP START EVENTS LOGGED ON 22-JUN-2021 AT 15:20:37 AND ON 23-JUN-2021 AT 06:16:23. REVIEW OF THE EVENT LOG FILE REVEALED THAT, PRIOR TO THE FIRST POWER UP EVENT, THE CONTROLLER LAST HAD POWER ON 04-OCT-2020. ADDITIONALLY, REVIEW OF THE DATA LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE FIRST POWER UP EVENT; THE FIRST DATA POINT WAS LOGGED ON 22-JUN-2021 AT 15:21:10, INDICATING THAT THE FIRST POWER UP EVENT OCCURRED DURING A CONTROLLER EXCHANGE. THE DATA POINT RECORDED PRIOR TO THE SECOND LOSS OF POWER REVEALED THAT AN ACTIVE ADAPTER WAS CONNECTED TO POWER PORT 1 AND (B)(4) WAS CONNECTED TO POWER PORT 2 WITH 93% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT NO POWER SOURCE WAS CONNECTED TO POWER PORT 1 AND (B)(4) WAS CONNECTED TO POWER PORT 2. THE CONTROLLER WAS WITHOUT POWER FOR 25 SECONDS. NO ANOMALIES WERE NOTED LEADING UP TO THE LOSS OF POWER. LOG FILE ANALYSIS ASSOCIATED WITH (B)(4) ALSO REVEALED MULTIPLE CONTROLLER POWER UP EVENTS WITH AN INCORRECT DATE STAMP. ANALYSIS OF THE (B)(4) ALARM LOG FILE REVEALED MULTIPLE CRITICAL BATTERY ALARMS LOGGED WITH AN INCORRECT DATE STAMP AND NO BATTERY CAPACITY, SERIAL NUMBER ID, OR CYCLE COUNT. LOG FILE ANALYSIS ASSOCIATED WITH (B)(4) REVEALED A CONTROLLER POWER UP EVENT WITH AN ASSOCIATED MOTOR START EVENT LOGGED ON 25-JUN-2021 AT 16:23:57. REVIEW OF THE EVENT LOG FILE REVEALED THAT, PRIOR TO THE POWER UP EVENT, THE CONTROLLER LAST HAD POWER ON 23-JUN-2021. ADDITIONALLY, REVIEW OF THE DATA LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE POWER UP EVENT; THE FIRST DATA POINT WAS LOGGED ON 25-JUN-2021 AT 16:24:31, INDICATING THAT THE POWER UP EVENT OCCURRED DURING A CONTROLLER EXCHANGE. LOG FILE ANALYSIS ALSO REVEALED FOUR (4) ADDITIONAL CONTROLLER POWER UPS WITH ASSOCIATED MOTOR START EVENTS LOGGED ON 27-JUN-2021 AT 15:05:48, 15:06:19, 15:11:28 AND 15:43:24, RESPECTIVELY. THE CONTROLLER WAS WITHOUT POWER FOR 17 SECONDS, 3 MINUTES AND 3 SECONDS, 5 MINUTES AND 50 SECONDS, 30 SECONDS, AND 16 SECONDS, RESPECTIVELY. ANALYSIS OF (B)(4) ALARM LOG FILE REVEALED MULTIPLE CRITICAL BATTERY ALARMS LOGGED WITH A BATTERY RELATIVE STATE OF CHARGE (RSOC) VALUE OF 101% LOGGED AND SERIAL NUMBER ID, OR CYCLE COUNT. REVIEW OF (B)(4) DATA LOG FILE REVEALED MULTIPLE DATA POINTS WITH A BATTERY RELATIVE STATE OF CHARGE (RSOC) VALUE OF 101% LOGGED WITH NO SERIAL NUMBER IDS OR CYCLE COUNTS, INDICATING THAT THE CONTROLLER WAS UNABLE TO RECOGNIZE THE CONNECTED BATTERIES AND LIKELY TRIGGERING POWER DISCONNECT ALARMS. IT IS LIKELY THE ABNORMAL RSOC VALUES ARE RELATED TO THE REPORTED COMMUNICATION ERROR EVENT. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE INITIAL CONTROLLER POWER UP EVENTS ON BOTH CONTROLLER CAN BE ATTRIBUTED TO CONTROLLER EXCHANGES. A POSSIBLE ROOT CAUSE OF THE REMAINING LOSSES OF POWER ON BOTH CONTROLLERS CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; THE MOST LIKELY ROOT CAUSE OF THE INABILITY OF THE CONTROLLER TO RECOGNIZE THE BATTERIES CAN BE ATTRIBUTED TO DAMAGED INTEG RATED CIRCUITS ON EACH OF THE CONTROLLERS' COMMUNICATION LINES. THE INTEGRATED CIRCUIT IS RESPONSIBLE FOR THE COMMUNICATION BETWEEN CONTROLLER AND BATTERIES AND IS ALSO CONNECTED TO THE REAL TIME CLOCK. THE DAMAGED INTEGRATED CIRCUITS LIKELY PREVENTED THE CONTROLLERS FROM DETERMINING THE CAPACITY OF BATTERIES, THEREFORE TRIGGERING POWER DISCONNECT ALARMS, CRITICAL BATTERY ALARMS AND THE ABNORMAL RSOC VALUES. 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.
ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 , MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-DEC-2018 / SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR?: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 29-DEC-2017. LABELED FOR SINGLE USE?: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-DEC-2016 / SERIAL #: (B)(4) / UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION? : NO. DEVICE EVALUATED BY MFR?: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-DEC-2015. LABELED FOR SINGLE USE?: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY , MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 30-SEP-2020/ SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION? : NO. DEVICE EVALUATED BY MFR?: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 03-SEP-2019. LABELED FOR SINGLE USE?: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-DEC-2016 / SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR?: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-DEC-2015. LABELED FOR SINGLE USE?: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-DEC-2016 / SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR?: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 31-DEC-2015. LABELED FOR SINGLE USE?: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 30-SEP-2020 / SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR?: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 03-SEP-2019. LABELED FOR SINGLE USE?: NO. (B)(4). 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 SEVERAL CRITICAL BATTERY ALARMS, COMMUNICATION ERRORS, AND LOSSES OF POWER TO THE CONTROLLER WITH ASSOCIATED VENTRICULAR ASSIST DEVICE (VAD) STOPS OCCURRED. IT WAS ALSO REPORTED THAT THE CONTROLLER WAS NOT RECOGNIZING THE BATTERIES WHEN CONNECTED. THE CONTROLLER WAS EXCHANGED WITH A SECOND CONTROLLER MULTIPLE TIMES WITH NO RESOLUTION OF ALARMS, SO THE PATIENT WAS HOSPITALIZED AND PUT ON WALL POWER UNTIL NEW BATTERIES ARRIVED. THE SECOND CONTROLLER AND ALL FIVE BATTERIES WERE THEN EXCHANGED AND REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1018549 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization | 1104 VAD| 1104 VAD |