ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
Report
- Report Number
- 3002808486-2018-00861
- Event Type
- Injury
- Date Received
- August 7, 2018
- Date of Event
- July 20, 2017
- Report Date
- November 27, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002236117
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113 G5) SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURERS REF# (B)(4). IMPLANT DATE CORRECTED. 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.
EXEMPTION NUMBER: E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF#: (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AS PER REVIEW OF THE IMAGING, AN ENTRY TEAR AT THE DISTAL MARGIN OF THE ZTEG-2PT-40-30-165-PF CONSISTENT WITH A STENT GRAFT-INDUCED NEW ENTRY (SINE) IS CONFIRMED. IT OCCURRED BETWEEN ON (B)(6) 2016 AND ON (B)(6) 2017. CHRONIC DISSECTION AND DISTAL FALSE LUMEN SIZE MISMATCH ARE RISK FACTORS FOR SINE (B)(6) SURG 2016;102:527-33 & (B)(6) SURG. 2017 MAR;65 (3):676-685). IN THIS CASE THE OVOID TRUE LUMEN JUST DISTAL THE ZTEG WAS MISMATCHED RELATIVE TO THE ROUNDER LUMEN MAINTAINED BY THE ZTEG. UNTIL IT WAS ELIMINATED, FALSE LUMEN PERFUSION BY THE DISTAL ENTRY TEAR CELIAC ARTERY CONTRIBUTED TO THE SIZE MISMATCH BY COMPRESSING THE FALSE LUMEN. THE MISMATCH AND INHERENTLY BRITTLE INTIMA OF A CHRONIC DISSECTION LIKELY LED TO THE SINE. THE SINE WAS ELIMINATED WITH A STENT FROM ANOTHER MANUFACTURER, HOWEVER BECAUSE ITS DISTAL END IS ALSO CONTAINED TO A 25X28MM OVAL, IT IS AT RISK OF CAUSING A SECOND SINE. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2015: A MALE PATIENT UNDERWENT TEVAR WITH THE DEVICE. THE PATIENT WAS NOT SUITABLE FOR THE PROCEDURE SINCE THE DEVICE WAS USED IN A SUB-ACUTE PHASE THOUGH, THE PHYSICIAN CONDUCTED THE PROCEDURE IN HOPES OF VESSEL REMODELING. ((B)(4)) ON (B)(6) 2017: NEW TEAR OR NEW DISSECTION FORMATION WAS CONFIRMED. ADDITIONAL INFORMATION RECEIVED 12JUL2018: ON (B)(6) 2017: DEVELOPMENT OF NEW DISSECTION DUE TO NEW TEAR FORMATION WAS CONFIRMED. THE LOCATION OF THE DISSECTION WAS AT THE DISTAL END OF THE STENT GRAFT IN THE LESSER CURVATURE OF THE AORTA. ON (B)(6) 2017: STENT GRAFT WAS ADDITIONALLY PLACED SUCCESSFULLY. THE PATIENT RECOVERED AFTER THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 17JUL2018: PRIMARY TEAR: AORTA AT LSA. PROCEDURE PERFORMED (B)(6) 2015. ADDITIONAL ADJUNCTIVE PROCEDURES PERFORMED DURING THE PROCEDURE 1. CSBYP 2.CAROTID-SUBCLAVIAN BYPASS; 2. LSAEMB 25.LSA EMBOLIZATION. THORACIC: PARTIALLY THROMBOSED. SECONDARY TEAR: DESCENDING AORTA CONTRAST CT SCAN PERFORMED (B)(6) 2015: FALSE LUMEN, THORACIC: PARTIALLY THROMBOSED. SECONDARY TEAR: DESCENDING AORTA CONTRAST CT SCAN PERFORMED (B)(6) 2015: FALSE LUMEN, THORACIC: PARTIALLY THROMBOSED. COLLATERAL: INTERCOSTAL ARTERY ABDOMINAL: PARTIALLY THROMBOSED. SECONDARY TEAR: CA. CONTRAST CT SCAN PERFORMED (B)(6) 2015: FALSE LUMEN, THORACIC: PARTIALLY THROMBOSED. COLLATERAL: INTERCOSTAL ARTERY ABDOMINAL: PARTIALLY THROMBOSED. SECONDARY TEAR: CA. CONTRAST CT SCAN PERFORMED (B)(6) 2016: FALSE LUMEN, THORACIC: PARTIALLY THROMBOSED. SECONDARY TEAR: CA INDICATION FOR MIGRATION ((>10 MM) OF COVERED STENT-GRAFT CRANIALLY. CONTRAST CT SCAN PERFORMED (B)(6) 2017: FALSE LUMEN, THORACIC: PARTIALLY THROMBOSED. SECONDARY TEAR: CA. CONTRAST CT SCAN PERFORMED (B)(6) 2018: FALSE LUMEN, THORACIC: COMPLETELY THROMBOSED ABDOMINAL: COMPLETELY THROMBOSED ON (B)(6) 2017- NEW TEAR FORMATION (NEIGHBORING REGION OF STENT-GRAFT.) COVERED STENT-GRAFT PLACED. SECONDARY INTERVENTION SUCCESSFUL. ADDITIONAL INFORMATION RECEIVED 18JUL2018: IT WAS CONFIRMED THAT THE LOCATION OF THE NEW DISSECTION WAS AT THE DISTAL END OF THE STENT GRAFT IN THE LESSER CURVATURE OF THE AORTA. PATIENT OUTCOME: THE PATIENT RECOVERED AFTER THE PROCEDURE
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596624 | ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3300982 | 10827002236117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |