HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-05045
- Event Type
- Injury
- Date Received
- May 11, 2022
- Date of Event
- May 2, 2022
- Report Date
- July 27, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION.
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) MEDICAL CENTER (B)(6) F4 CONTACT PERSON: (B)(6) F5 PHONE NUMBER: (B)(6) F6 DATE USER FACILITY BECAME AWARE OF THE EVENT: F7 TYPE OF REPORT: INITIAL F8 DATE OF THIS REPORT: JUN-2022 F9 APPROXIMATE AGE OF DEVICE: F10 EVENT PROBLEM CODES: F11 REPORT SENT TO FDA: F12 LOCATION WHERE EVENT OCCURRED: HOSPITAL, OTHER: SKILLED NURSING UNIT F13 REPORT SENT TO MANUFACTURER: YES, JUN-2022 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION AND INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) (B)(6) WAS NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS PERTAINING TO (B)(6) REVEALED A BRIEF DECREASE IN ESTIMATED FLOWS STARTING ON 20-APR-2022 FOLLOWED BY A RETURN TO BASELINE PARAMETERS. ADDITIONALLY, THIRTY-FOUR (34) LOW FLOW ALARMS HAVE BEEN LOGGED SINCE 18-APR-2022. AS A RESULT, THE REPORTED LOW FLOW EVENT WAS CONFIRMED. LOG FILES PERTAINING TO (B)(6) AND (B)(6) REVEALED THAT THESE CONTROLLERS WERE NOT IN USE DURING THE REPORTED EVENT DATE. INFORMATION RECEIVED FROM THE SITE INDICATED THAT, IN ADDITION TO THE LOW FLOW EVENT, THE PATIENT EXPERIENCED A HEMORRHAGIC CEREBROVASCULAR ACCIDENT (CVA) IN THE SETTING OF SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR). THE PATIENT EXPERIENCED LEFT-SIDED WEAKNESS, AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE BRAIN/HEAD CONFIRMED AN ACUTE SUBARACHNOID HEMORRHAGE. 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 GRA FT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. PER THE INSTRUCTIONS FOR USE, NEUROLOGICAL DYSFUNCTION IS A KNOWN POTENTIAL COMPLICATION 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 NEUROLOGICAL DYSFUNCTION. 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 PATIENT EXPERIENCED A HEMORRHAGIC CEREBROVASCULAR ACCIDENT (CVA) IN THE SETTING OF SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR). THE PATIENT EXPERIENCED LEFT-SIDED WEAKNESS, AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE BRAIN/HEAD CONFIRMED AN ACUTE SUBARACHNOID HEMORRHAGE. IT WAS NOTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED MULTIPLE LOW FLOWS AND A LOWER TROUGH, THOUGH IT WAS REPORTED THAT THIS WAS BASELINE FOR THE PATIENT. NEUROLOGY WAS CONSULTED. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT THE PATIENT STARTED HAVING THE SYMPTOMS THE DAY PRIOR WHILE INPATIENT. IT WAS NOTED THAT THE SYMPTOM WAS NOT WHAT BROUGHT THE PATIENT TO THE HOSPITAL. THE PATIENT¿S INTERNATIONAL NORMALIZED RATIO (INR) THREE WEEKS PRIOR WAS THERAPEUTIC AT 2.0 AND WAS 1.8 THE FOLLOWING DAY. THE PATIENT'S COMPLAINTS WERE NOTED IN THE SETTING OF SUPRATHERAPEUTIC INR. THE CT SCAN WAS ORDERED UPON THE PATIENT¿S REPORT OF SYMPTOMS. IT WAS NOTED THAT LOG FILES WERE OBTAINED TO RULE OUT ELEVATED PUMP POWERS WHICH WOULD SUGGEST AN EMBOLUS TRAVELING THROUGH THE PUMP TO THE BRAIN. LOG FILES DID NOT SHOW POWER SPIKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2036313 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other| H |