ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT
Report
- Report Number
- 3002808486-2016-00605
- Event Type
- Injury
- Date Received
- June 27, 2016
- Date of Event
- January 6, 2016
- Report Date
- January 6, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002526829
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER REF# (B)(4). INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
MANUFACTURER REF# PR150003 INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
MANUFACTURERS REF# (B)(4). COOK RECEIVED ADDITIONAL INFORMATION ON 25JUL2022. DUE TO THE ADDITIONAL INFORMATION A RE-INVESTIGATION HAS BEEN PERFORMED. SUMMARY OF INVESTIGATIONAL FINDINGS: THIS 61-YEAR-OLD FEMALE PATIENT WITH HISTORY OF CAD, VALVULAR HEART DISEASE, HYPERTENSION, A PREVIOUSLY TREATED THORACIC AORTIC ANEURYSM AND WHO WAS ENROLLED IN THE FRENCH REIMBURSEMENT STUDY WAS TREATED FOR A RUPTURED THORACIC ANEURYSM ON (B)(6) 2015 WITH A ZTEG-2P-30-140-PF (COMPLAINT DEVICE). THE STENT GRAFT WAS IMPLANTED WITHOUT DIFFICULTY. THE LEFT SUBCLAVIAN ARTERY (LSA) WAS NOT COVERED. NO ADDITIONAL PROCEDURES WERE PERFORMED AND THERE WERE NO UNCORRECTED ENDOLEAKS ON THE COMPLETION ANGIO. ON 06NOV2015 (1 DAY PP), A FOLLOW-UP X-RAY SHOWED NO TECHNICAL OBSERVATIONS OR IMAGING ABNORMALITIES, INCLUDING KINK, STENT FRACTURE, OR COLLAPSE OF THE PROXIMAL COMPONENT. ON 18NOV2015 (13 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS EXPERIENCING BACK AND CHEST PAIN AND COMPRESSION OF THE ESOPHAGUS AT THE TIME OF HOSPITAL ADMISSION. ON 03JAN2016 (59 DAYS PP), THE PATIENT WAS FOUND TO HAVE AN AORTOESOPHAGEAL FISTULA. ON (B)(6) 2016 (62 DAYS PP), THE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR. THE THORACIC AORTIC STENT GRAFT WAS EXPLANTED. PER THE REPORTED ADDITIONAL INFORMATION, THE MOST PROBABLE IS THAT THE FISTULA WAS ALREADY THERE BUT NOT DIAGNOSED AT PRESENTATION. ON 07JAN2016 (63 DAYS PP), THE PATIENT WAS FOUND TO HAVE A DVT AND WAS TREATED WITH MEDICATION. PROLONGED HOSPITALIZATION WAS REQUIRED. PER THE ADDITIONAL INFORMATION PROVIDED ON 30JUN2022, ON 11JAN2016 UPON EXPLANT OF THE STUDY DEVICE, THE SITE HAS REPORTED "E COLI AND STREPTOCOCCUS INFECTION OF THE PROTHESIS", TREATED WITH MEDICATION. EVENT END DATE IS NOTED AS 03MAR2016. THE SITE HAS DEEMED THE EVENT RELATED TO BOTH STUDY DEVICE AND PROCEDURE. INFECTION OF ENDOGRAPH WAS CONFRONT AFTER EXPLANATION. ADDITIONALLY, THE FISTULA AND THE INFECTION WAS DETERMINED ON THE FOLLOW-UP CTA AT THE SAME TIME BASED ON INDIRECT SIGNS AS HYPERTHERMIA, HEMATEMESIS AND PERIGRAFT AIR BUBBLES. AND UPPER ENDOSCOPY REVEALED A LARGE ESOPHAGAL ULCERATION. A POSTOPERATIVE CT STUDY DATED 01MAR2016 (2 MONTHS POSTOP) WAS PROVIDED ALONG WITH THE COMPLAINT REPORT AND REVIEWED BY AN IMAGING EXPERT. PER THE IMPRESSIONS IN THE IMAGING REVIEW ¿AT 2 MONTHS POSTOP, THERE IS AIR AROUND THE ZTEG GRAFT WITHIN THE TAA SAC WITH ADJACENT STRANDING AND ESOPHAGEAL WALL THICKENING, HIGHLY SUSPICIOUS FOR AN AORTO-ESOPHAGEAL FISTULA. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPORTED AS ¿E COLI AND STREPTOCOCCUS INFECTION OF THE PROSTHESIS.¿ ALSO, PER THE IMPRESSIONS IN THE IMAGING REVIEW¿ IT CANNOT BE DETERMINED IF THIS WAS A PRIMARY FISTULA RESULTING IN GRAFT INFECTION OR VICE VERSA. THE MOST LIKELY CAUSES OF THIS FISTULA ARE INTRAOPERATIVE GRAFT CONTAMINATION OR PRESENCE OF A MICRO FISTULA ALREADY AT THE TIME OF REPAIR. THE REPORT STATES THERE WAS COMPRESSION OF THE ESOPHAGUS BY THE ANEURYSM AND POSSIBLE SAC RUPTURE AT THE TIME OF REPAIR. THIS MAY HAVE CAUSED THE FISTULA FORMATION. OTHER POSSIBLE CAUSES, BUT LESS LIKELY, ARE SYSTEMIC BACTEREMIA FROM ANOTHER SOURCE RESULTING IN GRAFT INFECTION (E. COLI FROM A LOCAL INFECTION WOULD BE UNUSUAL HERE), OR GRAFT EROSION INTO THE ADJACENT ESOPHAGEAL WALL FROM GRAFT EXPANSION (ALTHOUGH THE GRAFT DOES NOT APPEAR TO BE DIRECTLY PRESSING AGAINST THE ESOPHAGEAL WALL)¿. THE EXPLANTED STENT GRAFT WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATION. BASED ON THE PROVIDED INFORMATION AND IMAGING REVIEW, IT WAS NOT POSSIBLE TO DETERMINE WHETHER THIS WAS A PRIMARY FISTULA RESULTING IN STENT GRAFT INFECTION OR CONVERSELY. HOWEVER, COMPRESSION OF THE ESOPHAGUS BY THE ANEURYSM AND POSSIBLE SAC RUPTURE AT THE TIME OF REPAIR MAY HAVE CAUSED THE FISTULA FORMATION. A SYSTEMIC BACTEREMIA FROM ANOTHER SOURCE RESULTING IN GRAFT INFECTION, OR GRAFT EROSION INTO THE ADJACENT ESOPHAGEAL WALL FROM GRAFT EXPANSION COULD BE THE POSSIBLE CAUSES BUT LESS LIKELY. IT IS NOTED THAT THE COMPLAINT DEVICE WAS USED FOR TREATMENT OF RUPTURED ANEURYSM. ACCORDING TO THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE ZENITH TX2 TAA ENDOVASCULAR GRAFT WITH PRO-FORM WITH THE Z-TRAK PLUS INTRODUCTION SYSTEM HAS NOT BEEN EVALUATED IN THE PATIENTS WITH LEAKING, PENDING RUPTURE OR RUPTURED ANEURYSM. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ON 11JAN2016 UPON EXPLANT OF THE STUDY DEVICE, THE SITE HAS REPORTED "E COLI AND STREPTOCOCCUS INFECTION OF THE PROTHESIS", TREATED WITH MEDICATION. EVENT END DATE IS NOTED AS 03MAR2016. THE SITE HAS DEEMED THE EVENT RELATED TO BOTH STUDY DEVICE AND PROCEDURE. FURTHER COMMENT WAS PROVIDED: "INFECTION OF ENDOGRAPH WAS CONFRONT AFTER EXPLANTATION".
ADDITIONAL INFORMATION RECEIVED ON 25JUL2022: WHEN WAS THE FISTULA DETERMINED, BEFORE OR AFTER THE INFECTION WAS DETERMINED? BOTH AT THE SAME TIME ON FU CTA BASED ON INDIRECT SIGNS : HYPERTHERMIA, HEMATEMESIS, PERIGRAFT AIR BUBBLES. AND UPPER ENDOSCOPY REVEALED A LARGE ¿SOPHAGAL ULCERATION.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
(B)(4). SIMILAR TO DEVICE WITH 510(K) P070016. INVESTIGATION IS STILL IN PROGRESS
(B)(4). SIMILAR TO DEVICE WITH 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INFORMATION PROVIDED IN THIS COMPLAINT FILE, THE PRESENCE OF AN AORTOESOPHAGEAL FISTULA WAS CONFIRMED. HOWEVER, AS NO IMAGING WAS PROVIDED, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE FISTULA, LOCATION OF THE FISTULA IN RELATION TO THE ZENITH TX2 TAA ENDOVASCULAR GRAFT OR LOCATION OF THE FISTULA IN RELATION TO A POSSIBLE GRAFT FROM THE PREVIOUSLY TREATED THORACIC AORTIC ANEURYSM. IT IS POSSIBLE THAT INDIVIDUAL PATIENT FACTORS (ANATOMY AND/OR DISEASE STATE) OR THE USE OF THE DEVICE CONTRIBUTED TO THE EVENTS REPORTED IN THIS COMPLAINT. AS PER IFU AORTO-ESOPHAGEAL FISTULA IS A KNOWN POTENTIAL ADVERSE EVENT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO STUDY: THIS (B)(6) FEMALE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR DUE TO AN AORTOESOPHAGEAL FISTULA 62 DAYS POST-PROCEDURE. ON (B)(6) 2015, A PROXIMAL COMPONENT (ZTEG-2P-30-140-PF, LOT # E3332073) WAS IMPLANTED WITHOUT DIFFICULTY. THE LEFT SUBCLAVIAN ARTERY (LSA) WAS NOT COVERED. NO ADDITIONAL PROCEDURES WERE PERFORMED AND THERE WERE NO UNCORRECTED ENDOLEAKS ON THE COMPLETION ANGIO. ON (B)(6) 2015 (1 DAY PP), A FOLLOW-UP X-RAY SHOWED NO TECHNICAL OBSERVATIONS OR IMAGING ABNORMALITIES, INCLUDING KINK, STENT FRACTURE, OR COLLAPSE OF THE PROXIMAL COMPONENT. ON (B)(6) 2015 (13 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2016 (59 DAYS PP), THE PATIENT WAS FOUND TO HAVE AN AORTOESOPHAGEAL FISTULA. ON (B)(6) 2016 (62 DAYS PP), THE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR. THE THORACIC AORTIC STENT GRAFT WAS EXPLANTED. PATIENT OUTCOME: AFTER THE CONVERSION TO OPEN REPAIR ON (B)(6) 2016 (62 DAYS PP), THE PATIENT DEVELOPED A DVT WHICH PROLONGED HER HOSPITALIZATION.
DESCRIPTION OF EVENT ACCORDING TO STUDY: THIS (B)(6) FEMALE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR DUE TO AN AORTOESOPHAGEAL FISTULA 62 DAYS POST-PROCEDURE. ON (B)(6) 2015, A PROXIMAL COMPONENT (ZTEG-2P-30-140-PF, LOT # E3332073) WAS IMPLANTED WITHOUT DIFFICULTY. THE LEFT SUBCLAVIAN ARTERY (LSA) WAS NOT COVERED. NO ADDITIONAL PROCEDURES WERE PERFORMED AND THERE WERE NO UNCORRECTED ENDOLEAKS ON THE COMPLETION ANGIO. ON (B)(6) 2015 (1 DAY PP), A FOLLOW-UP X-RAY SHOWED NO TECHNICAL OBSERVATIONS OR IMAGING ABNORMALITIES, INCLUDING KINK, STENT FRACTURE, OR COLLAPSE OF THE PROXIMAL COMPONENT. ON (B)(6) 2015 (13 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2016 (59 DAYS PP), THE PATIENT WAS FOUND TO HAVE AN AORTOESOPHAGEAL FISTULA. ON (B)(6) 2016 (62 DAYS PP), THE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR. THE THORACIC AORTIC STENT GRAFT WAS EXPLANTED. ON (B)(6) 2016 (63 DAYS PP), THE PATIENT WAS FOUND TO HAVE A DVT AND WAS TREATED WITH MEDICATION. PATIENT OUTCOME: AFTER THE CONVERSION TO OPEN REPAIR ON (B)(6) 2016 (62 DAYS PP), THE PATIENT DEVELOPED A DVT WHICH PROLONGED HER HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407131 | ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3332073 | 10827002526829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Life Threatening |