HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-02642
- Event Type
- Injury
- Date Received
- February 23, 2022
- Date of Event
- August 1, 2018
- Report Date
- April 29, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER; UDI #: (B)(4). D9: NO; H5: NO; H6: PATIENT IME CODE(S): E0506, E0119, E0139, E060109, E1019, E233601 H6: IMF CODE(S): F1203, F08, F2202, F2203, F2302 H6: IMG CODE(S): G04035 H6: FDA DEVICE CODE(S): A1203 H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16 ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE CONTROLLER, 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. 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 AS ADDITIONAL INFORMATION HAS BEING RECEIVED FOR THIS EVENT. UPDATED SECTION: B5 DESC EVT PROBLEM ADDITIONAL PRODUCT: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 1.0 D4: MODEL #: 1403/ CATALOG #: 1403/ EXPIRATION DATE: 31-AUG-2017 / SERIAL OR LOT#: (B)(6) UDI #:(B)(4) D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: (B)(6) 2016 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. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 PRODUCT EVENT SUMMARY: THE PUMP AND ONE CONTROLLER WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE CONTROLLER LOG FILES PERTAINING TO THE CONTROLLER REVEALED NO LOSSES OF POWER TO THE CONTROLLER ON THE REPORTED EVENT DATE. LOG FILE ANALYSIS DID NOT REVEAL ANY ANOMALIES LOGGED WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED CONTROLLER ¿COMPLETE POWER DISCONNECT¿ EVENT COULD NOT BE CONFIRMED. INFORMATION PROVIDED BY THE SITE INDICATED THAT THE PATIENT EXPERIENCED A MASSIVE GASTROINTESTINAL BLEED ASSOCIATED WITH SHOCK DUE TO A MALLORY WEISS TEAR IN THE LOWER ESOPHAGUS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED AFTER BEING FOUND DOWN WITH MELENA IN THE SETTING OF SUPRATHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR). THE PATIENT WAS NOTED TO HAVE EXPERIENCED VENTRICULAR TACHYCARDIA (VT), CARDIOGENIC AND DISTRIBUTIVE SHOCK ON VASOACTIVE AGENTS, AND ALTERED MENTAL STATUS. THE PATIENT WAS CARDIOVERTED AND INTUBATED. INOTROPES AND VASOPRESSORS WERE WEANED OFF AND THE PATIENT WAS EXTUBATED. THE PATIENT WAS TRANSFUSED THREE UNITS OF PACKED RED BLOOD CELLS. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) REVEALED NO FURTHER EVIDENCE BLEEDING FROM THE MALLORY WEISS TEAR. THE PATIENT'S ASPIRIN DOSE WAS REDUCED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, BLEEDING, SYNCOPE AND CARDIAC ARRHYTHMIA ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. BASED ON REVIEW OF PAST ADVERSE EVENTS FOR THIS PATIENT, IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF CARDIAC ARRHYTHMIA. 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. 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 REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT EXPERIENCED A MASSIVE GASTROINTESTINAL BLEED ASSOCIATED WITH SHOCK DUE TO A MALLORY WEISS TEAR IN THE LOWER ESOPHAGUS. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED AFTER BEING FOUND DOWN WITH MELENA IN THE SETTING OF SUPRATHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR). THE PATIENT WAS NOTED TO HAVE EXPERIENCED VENTRICULAR TACHYCARDIA (VT), CARDIOGENIC AND DISTRIBUTIVE SHOCK ON VASOACTIVE AGENTS, AND ALTERED MENTAL STATUS. THE PATIENT WAS CARDIOVERTED AND INTUBATED. INOTROPES AND VASOPRESSORS WERE WEANED OFF AND THE PATIENT WAS EXTUBATED. REVIEW OF DATA LOG FILES REVEALED THAT THE CONTROLLER HAD A COMPLETE POWER DISCONNECT, LEADING TO THE PATIENT PERFORMING A CONTROLLER EXCHANGE ON THEIR OWN. THE PATIENT WAS RE-EDUCATED ON POWER SOURCE MANAGEMENT AND APPROPRIATENESS OF A CONTROLLER EXCHANGE. THE PATIENT WAS TRANSFUSED THREE UNITS OF PACKED RED BLOOD CELLS. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) REVEALED NO FURTHER EVIDENCE BLEEDING FROM THE MALLORY WEISS TEAR. THE PATIENT'S ASPIRIN DOSE WAS REDUCED.
IT WAS FURTHER REPORTED THAT THE EXCHANGED CONTROLLER WAS DISPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 929474 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male | Other| H| L| R |