HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-04727
- Event Type
- Injury
- Date Received
- April 19, 2022
- Date of Event
- April 1, 2022
- Report Date
- February 15, 2023
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS CONFIRMED VIA LOG FILE ANALYSIS WHICH REVEALED INTERMITTED DECREASES IN ESTIMATED FLOWS WITHIN THE ANALYZED PERIOD, FOLLOWED BY A SLIGHT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOW STARTING ON (B)(6) 2022 AND ONE LOW FLOW ALARM WAS LOGGED ON (B)(6) 2022. INFORMATION PROVIDED BY THE SITE INDICATED THAT, IN ADDITION TO THE LOW FLOW EVENT, THE PATIENT PRESENTED WITH CHEST DISCOMFORT AND DIFFICULTY BREATHING. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FLUID REPLACEMENT AND THE PATIENT'S CONDITION WAS MONITORED. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS PERFORMED AND A CARDIAC COLLAPSE (VERY SMALL) WAS CONFIRMED. A VAD THROMBOSIS WAS SUSPECTED, HOWEVER, NO CLEAR THROMBUS FORMATION FINDINGS SUCH AS INCREASE IN LACTATE DEHYDROGENASE (LDH) AND FREE HEMOGLOBIN (FHB) WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBOSIS 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 THROMBUS EVENTS. 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, POOR VAD FILLING, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION HAS BEING RECEIVED FOR THIS EVENT. UPDATED SECTION: A4 WEIGHT IN LBS B5 DESC EVT PROBLEM B6 LABORATORY DATA H6 H6: PATIENT IME CODE(S), H6: IMF CODE(S) 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 IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. PRODUCT EVENT SUMMARY: VENTRICULAR ASSIST DEVICE (VAD) (B)(6) WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS CONFIRMED VIA LOG FILE ANALYSIS WHICH REVEALED INTERMITTED DECREASES IN ESTIMATED FLOWS WITHIN THE ANALYZED PERIOD, FOLLOWED BY A SLIGHT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOW STARTING ON 30-MAR-2022 AND ONE (1) LOW FLOW ALARM WAS LOGGED ON 01-APR-2022. INFORMATION PROVIDED BY THE SITE INDICATED THAT, IN ADDITION TO THE LOW FLOW EVENT, THE PATIENT PRESENTED WITH CHEST DISCOMFORT AND DIFFICULTY BREATHING. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FLUID REPLACEMENT AND THE PATIENT'S CONDITION WAS MONITORED. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS PERFORMED AND A CARDIAC COLLAPSE (VERY SMALL) WAS CONFIRMED. A VAD THROMBOSIS WAS SUSPECTED, HOWEVER, NO CLEAR THROMBUS FORMATION FINDINGS SUCH AS INCREASE IN LACTATE DEHYDROGENASE (LDH) AND FREE HEMOGLOBIN (FHB) WERE OBSERVED. IT WAS FURTHER REPORTED THAT THE PATIENT ALSO EXPERIENCED UPPER GASTROINTESTINAL (GI) BLEEDING. AN ARGON PLASMA COAGULATION (APC) ABLATION WAS PERFORMED. THE PATIENT WAS TRANSFUSED WITH FOUR UNITS OF PACKED RED BLOOD CELLS (PRBCS) AND MEDICATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBOSIS AND BLEEDING ARE 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 THROMBUS AND BLEEDING EVENTS. 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, POOR VAD FILLING, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRE SSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE IS 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 DEVELOPED SYMPTOMS IN THE CHEST. THE PATIENT WENT TO THE HOSPITAL FOR AN EMERGENCY VISIT. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS PERFORMED AND A CARDIAC COLLAPSE (VERY SMALL) WAS CONFIRMED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FLUID REPLACEMENT AND THE PATIENT'S CONDITION WAS MONITORED. IT WAS ALSO REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR CHEST DISCOMFORT AND DIFFICULTY IN BREATHING JUST LIKE THE LAST TIME. A VAD THROMBOSIS WAS SUSPECTED DUE TO THE SAME SYMPTOMS AS THE LAST TIME, BUT NO CLEAR THROMBUS FORMATION FINDINGS SUCH AS INCREASE IN LACTATE DEHYDROGENASE (LDH) AND FREE HEMOGLOBIN (FHB) WERE OBSERVED. THE FLOW TENDS TO DROP SOMETIMES FROM 5.0 LITER / MINUTE TO 4.0 LITER / MINUTE WHEN THE PATIENT'S BODY POSITION WAS CHANGED. THIS WAS MANAGED BY LIFTING THE HEAD SIDE OF THE BED. 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 ALSO EXPERIENCED UPPER GASTROINTESTINAL BLEEDING. AN ARGON PLASMA COAGULATION (APC) ABLATION WAS PERFORMED. THE PATIENT WAS TRANSFUSED WITH FOUR UNIT OF PACKED RED BLOOD CELLS (PRBC) AND MEDICATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 659230 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male | Required Intervention| L| H |