HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE
Report
- Report Number
- 3007042319-2021-06037
- Event Type
- Injury
- Date Received
- August 20, 2021
- Date of Event
- June 16, 2021
- Report Date
- February 8, 2024
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707003261
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION: - B5 DESC EVT PROBLEM: UPDATED TO INCLUDE ADDITIONAL INFORMATION SURROUNDING THE REASON FOR ADMISSION AND ANTICOAGULATION MEDICATION MANAGEMENT - H6 PATIENT CODES (IME/ANNEX E): UPDATED TO INCLUDE CODE "E1901" 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 FOR UPDATE TO INVESTIGATION COMPLETION. THE PRODUCT EVENT SUMMARY WAS REVISED. REVISED PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (B)(6) WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED A DRIVELINE INFECTION WHICH WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. THE PATENT HAD CHRONIC DRAINAGE FROM THE DRIVELINE EXIT SITE AND WAS ON CHRONIC ANTIBIOTICS WITH AN ANTIBIOTIC BEAD PLACED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD INITIALLY BEEN ADMITTED FOR SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR) AND THAT THE PATIENT¿S MOTHER HAD MISHEARD BLOOD THINNERS ADMINISTRATION INSTRUCTIONS IN THE CLINIC AND HAD BEEN GIVING THE PATIENT LOWER DOSES; EDUCATION AND HOME HEALTH SERVICES WERE ARRANGED. OF NOTE, THE PATIENT WAS GRAM POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, INFECTION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. 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, INCLUDING CARE OF THE DRIVELINE EXIT SITE. 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 FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: (B)(6) WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED A DRIVELINE INFECTION. THE PATENT HAD CHRONIC DRAINAGE FROM THE DRIVELINE EXIT SITE AND WAS ON CHRONIC ANTIBIOTICS WITH AN ANTIBIOTIC BEAD PLACED. THE PATIENT WAS ALSO HOSPITALIZED AND TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION OR PERFORMANCE ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, INFECTION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF SIMILAR ADVERSE EVENTS. 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 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 AND SECTIONS HAVE BEEN UPDATED. INVESTIGATION OF THIS EVENT WAS 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 FURTHER REPORTED THAT THE PATIENT HAD INITIALLY BEEN ADMITTED FOR SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR) AND THAT THE PATIENT¿S MOTHER HAD MISHEARD BLOOD THINNERS ADMINISTRATION INSTRUCTIONS IN THE CLINIC AND HAD BEEN GIVING THE PATIENT LOWER DOSES. VENTRICULAR ASSIST DEVICE (VAD) EDUCATION AND HOME HEALTH SERVICES WERE ARRANGED. OF NOTE, THE PATIENT WAS GRAM POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS.
IT WAS FURTHER REPORTED THAT THE PATIENT INFECTION HAD RETURNED, THE PATIENT WAS GRAM POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS. PATIENT WAS PLACED ON CHRONIC ANTIBIOTICS WITH AN ANTIBIOTIC BEAD PLACED.
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. THIS INFORMATION WAS RECEIVED FROM THE PRODUCT SURVEILLANCE REGISTRY (PSR) MECHANICAL CIRCULATORY SUPPORT (MCS) THERAPY BASE STUDY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DRIVELINE INFECTION. THE PATENT HAD CHRONIC DRAINAGE FROM THE DRIVELINE EXIT SITE AND WAS ON CHRONIC ANTIBIOTICS WITH AN ANTIBIOTIC BEAD PLACED. THE PATIENT WAS ALSO HOSPITALIZED AND TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. THE DRIVELINE 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 |
|---|---|---|---|---|---|---|---|
| 1248554 | HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707003261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male | Hospitalization| R |