ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Report
- Report Number
- 3002808486-2016-00352
- Event Type
- Injury
- Date Received
- June 1, 2016
- Date of Event
- April 20, 2016
- Report Date
- June 28, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002346618
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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). EVENT IS NO LONGER REPORTABLE IN THE US BASED ON THE COMPLETED INVESTIGATION. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404. REGISTRATION NO.: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT WAS REOPENED AS IMAGING WAS PROVIDED. A PATIENT RECEIVED A CMD-ZTA PROXIMAL AND A ZTA-PT-46-42-233 DISTAL (COMPLAINT DEVICE) ON 20APR2016 AND A TYPE 1B ENDOLEAK WAS LEFT UNCORRECTED ON THE COMPLETION ANGIOGRAM. ON ONE MONTH FOLLOW-UP (07JUN2016) CT IMAGING EXAM SHOWED EVIDENCE OF ENDOLEAK TYPE 1B FROM FALSE LUMEN BELOW THE END OF THE GRAFT. THE PATIENT WAS HOSPITALIZED FOR A SECONDARY INTERVENTION TO TREAT THIS TYPE IB ENDOLEAK ON 10OCT2016. ENDOVASCULAR PLACEMENT OF A FENESTRATED ENDOPROSTHESIS WAS PERFORMED. IMPLANTATION ANGIOGRAPHY AND SIX WEEKS POST IMPLANTATION CTA WERE PROVIDED AND REVIEWED. THE REVIEW SHOWED THAT THE DISTAL ENDOGRAFT WAS SEALED IN THE TRUE LUMEN. THE FALSE LUMEN STILL PERFUSED RETROGRADE FROM AN ENTRY TEAR INVOLVING THE LEFT POSTERIOR ABDOMINAL AORTIC INTIMA, OPPOSITE THE CELIAC ARTERY ORIGIN. ADDITIONALLY, THE REVIEWER STATES THAT "THE ENDOGRAFT REMAINED CONSTRAINED BY INTIMA THICKENED AND NON-COMPLIANT FROM CHRONIC DISSECTION. ALTHOUGH THIS PREVENTED THE GRAFT FROM OBLITERATING THE FALSE LUMEN, IT ALSO PERMITTED PERSISTENT PERFUSION OF THE SPINAL ARTERY VIA THE INTERCOSTAL ARTERIES." THE ENDOLEAK RELATED TO THE COMPLAINT DEVICE (B)(4) IS NOT CONFIRMED BASED ON THE REVIEW OF THE IMAGING PROVIDED. ALTHOUGH RETROGRADE FALSE LUMEN PERFUSION WAS CONFIRMED, THE PERFUSION DID NOT CONSTITUTE AN ENDOLEAK SINCE THE DISTAL GRAFT WAS COMPLETELY SEALED IN THE LUMEN. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
(B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: REINVESTIGATION DUE TO ADDITIONAL INFORMATION PROVIDED ON 08AUG2017. THE INVESTIGATION OF THIS COMPLAINT WAS BASED ON REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORDS AND THE INSTRUCTIONS FOR USE (IFU). BASED ON THE LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON REINVESTIGATION, IT IS CONCLUDED THAT THE PRODUCT WAS USED ACCORDING TO INDICATIONS. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. PER QUALITY ENGINEERING ASSESMENT, THE ASSOCIATED RISKS IDENTIFIED IN THIS ANALYSIS HAS BEEN DEEMED ACCEPTABLE. USE OF THIS DEVICE WILL NOT CREATE A REASONABLE PROBABILITY THAT ADVERSE HEALTH CONSEQUENCES WILL OCCUR. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). INVESTIGATION IS STILL IN PROGRESS.
(B)(4). INVESTIGATION IS STILL IN PROGRESS.
(B)(4). DEVICE IS SIMILAR TO DEVICE UNDER 510(K): P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED EVENT BASED ON THE INFORMATION CURRENTLY AVAILABLE. HOWEVER, IT WAS DETERMINED THAT THE PRODUCT WAS USED OFF LABEL, AS THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS NOT INDICATED FOR TREATMENT OF DISSECTIONS. THIS PRODUCT WAS IN THIS CASE USED FOR TREATMENT OF DISSECTION AS WELL AS ANEURYSM. ACCORDING TO THE IFU: - THE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR TREATMENT OF ANEURYSMS AND ULCERS IN THE DESCENDING THORACIC AORTA, NOT DISSECTIONS, AS IN THIS CASE. THE PRODUCT WAS USED OFF LABEL; - THE PERFORMANCE OF ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT HAS NOT BEEN TESTED AND ESTABLISHED IN THE TREATMENT OF AORTIC DISSECTIONS; - ENDOLEAK IS A KNOWN POTENTIAL ADVERSE EVENT. IT IS NOTED THAT NO NEW CLINICAL EVENT OR INTERVENTION HAS BEEN REPORTED DUE TO THE ENDOLEAK. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. THE COMPLAINT WILL BE CLOSED, AND REOPENED IF NEW INFORMATION IS PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2016, A PROXIMAL COMPONENT (CMD-ZTA-PT-6775-250316) AND A DISTAL COMPONENT (ZTA-PT-46-42-233) WERE IMPLANTED WITHOUT DIFFICULTY. AN LEFT SUBCLAVIAN ARTERY (LSA) REVASCULARIZATION WAS COMPLETED PRIOR TO THE IMPLANT PROCEDURE. THE LSA WAS COVERED COMPLETELY WITH THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION IN ZONE 0. A TYPE IB (DISTAL END) ENDOLEAK WAS LEFT UNCORRECTED ON THE COMPLETION ANGIOGRAM. THERE WAS ALSO EVIDENCE OF FALSE LUMEN PERFUSION FROM RESIDUAL FLOW OVER THE PRIMARY ENTRY. PATIENT OUTCOME: ON (B)(6) 2016 (10 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO SERIOUS ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PATIENT.
ADDITIONAL INFORMATION RECEIVED 08AUG2017: THIS (B)(6) YR OLD MALE PATIENT IN THE (B)(6) STUDY HAD A TYPE IB ENDOLEAK NOTED ON THE COMPLETION ANGIOGRAM. ADDITIONAL INFORMATION ADDED TO ENTRY OF 18APR2016: IMPLANT DATE CORRECTED TO (B)(6) 2016 AS DATE OF IMPLANT WAS PREVIOUSLY REPORTED AS (B)(6) 2016. ADDITIONAL INFORMATION ADDED TO ENTRY OF 20JUN2017: DATE OF ENTRY CORRECTED TO (B)(6) 2016 ONE RELATED SAE HAS BEEN REPORTED REGARDING THE TYPE IB ENDOLEAK ON (B)(6) 2017, DESCRIBED IN ADDITIONAL INFORMATION FROM 24JAN2017.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2016, A PROXIMAL COMPONENT (CMD-ZTA-PT-6775-250316) AND A DISTAL COMPONENT (ZTA-PT-46-42-233) WERE IMPLANTED WITHOUT DIFFICULTY. A LEFT SUBCLAVIAN ARTERY (LSA) REVASCULARIZATION WAS COMPLETED PRIOR TO THE IMPLANT PROCEDURE. THE LSA WAS COVERED COMPLETELY WITH THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION IN ZONE 0. A TYPE IB (DISTAL END) ENDOLEAK WAS LEFT UNCORRECTED ON THE COMPLETION ANGIOGRAM. THERE WAS ALSO EVIDENCE OF FALSE LUMEN PERFUSION FROM RESIDUAL FLOW OVER THE PRIMARY ENTRY. ADDITIONAL INFORMATION RECEIVED ON 18JAN2017: ON (B)(6) 2016, THE ONE MONTH FOLLOW-UP CT REVEALED A MAXIMUM ANEURYSM DIAMETER OF 72 MM AND A TOTAL LENGTH OF COVERED AORTA OF 326 MM. THE FALSE LUMEN WAS PATENT AT LEVEL OF STENTED SEGMENT OF THE AORTA. THERE WAS NO PROGRESSION OF THE DISSECTION. CT IMAGING EXAM SHOWED EVIDENCE OF ENDOLEAK TYPE 1B FROM FALSE LUMEN BELOW THE END OF THE GRAFT. THIS OBSERVATION WAS NOT PRESENT AT PREVIOUS FILM READ. THERE WAS EVIDENCE OF EXISTING FALSE LUMEN PERFUSION WITH THE SOURCE OF THE PERFUSION BEING RESIDUAL FLOW OVER PRIMARY ENTRY. NONE OF THESE OBSERVATIONS RESULTED IN AN INTERVENTION. THERE WAS NO EVIDENCE OF STENT GRAFT MIGRATION OR COLLAPSE OF PROXIMAL COMPONENT. ADDITIONAL INFORMATION RECEIVED ON 24JAN2017: ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED FOR A SECONDARY INTERVENTION TO TREAT THE TYPE IB ENDOLEAK. ENDOVASCULAR PLACEMENT OF A FENESTRATED ENDOPROSTHESIS WAS PERFORMED. THE INVESTIGATIVE SITE NOTED THE FOLLOWING: ¿THE ANGIO-SCANNER CONTROL ON (B)(6) 2016 SHOWS A PERMEABILITY OF THE DISPLACEMENT OF THE SUPRA-AORTIC TRUNKS AS WELL AS IN THE THORACO-ABDOMINAL ENDO-PROSTHESIS. HOWEVER, THERE EXISTS AT THE DISTAL PART OF THE PROSTHESIS A REENTRY DOOR FEEDING RETROGRADE THE THORACIC ANEURYSM. THERE IS THEREFORE A RISK OF RUPTURE.¿ SEVERAL QUERIES HAVE BEEN PLACED TO CLARIFY INFORMATION. PATIENT OUTCOME: ON (B)(6) 2016 (10 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO SERIOUS ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PATIENT. ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED FOR A SECONDARY INTERVENTION TO TREAT THE TYPE IB ENDOLEAK. ENDOVASCULAR PLACEMENT OF A FENESTRATED ENDOPROSTHESIS WAS PERFORMED.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2016, A PROXIMAL COMPONENT (CMD-ZTA-PT-6775-250316) AND A DISTAL COMPONENT (ZTA-PT-46-42-233) WERE IMPLANTED WITHOUT DIFFICULTY. A LEFT SUBCLAVIAN ARTERY (LSA) REVASCULARIZATION WAS COMPLETED PRIOR TO THE IMPLANT PROCEDURE. THE LSA WAS COVERED COMPLETELY WITH THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION IN ZONE 0. A TYPE IB (DISTAL END) ENDOLEAK WAS LEFT UNCORRECTED ON THE COMPLETION ANGIOGRAM. THERE WAS ALSO EVIDENCE OF FALSE LUMEN PERFUSION FROM RESIDUAL FLOW OVER THE PRIMARY ENTRY. ADDITIONAL INFORMATION RECEIVED ON 18JAN2017: ON (B)(6) 2016, THE ONE MONTH FOLLOW-UP CT REVEALED A MAXIMUM ANEURYSM DIAMETER OF 72 MM AND A TOTAL LENGTH OF COVERED AORTA OF 326 MM. THE FALSE LUMEN WAS PATENT AT LEVEL OF STENTED SEGMENT OF THE AORTA. THERE WAS NO PROGRESSION OF THE DISSECTION. CT IMAGING EXAM SHOWED EVIDENCE OF ENDOLEAK TYPE 1B FROM FALSE LUMEN BELOW THE END OF THE GRAFT. THIS OBSERVATION WAS NOT PRESENT AT PREVIOUS FILM READ. THERE WAS EVIDENCE OF EXISTING FALSE LUMEN PERFUSION WITH THE SOURCE OF THE PERFUSION BEING RESIDUAL FLOW OVER PRIMARY ENTRY. NONE OF THESE OBSERVATIONS RESULTED IN AN INTERVENTION. THERE WAS NO EVIDENCE OF STENT GRAFT MIGRATION OR COLLAPSE OF PROXIMAL COMPONENT. ADDITIONAL INFORMATION RECEIVED ON 24JAN2017: ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED FOR A SECONDARY INTERVENTION TO TREAT THE TYPE IB ENDOLEAK. ENDOVASCULAR PLACEMENT OF A FENESTRATED ENDOPROSTHESIS WAS PERFORMED. THE INVESTIGATIVE SITE NOTED THE FOLLOWING: ¿THE ANGIO-SCANNER CONTROL ON (B)(6) 2016 SHOWS A PERMEABILITY OF THE DISPLACEMENT OF THE SUPRA-AORTIC TRUNKS AS WELL AS IN THE THORACO-ABDOMINAL ENDO-PROSTHESIS. HOWEVER, THERE EXISTS AT THE DISTAL PART OF THE PROSTHESIS A REENTRY DOOR FEEDING RETROGRADE THE THORACIC ANEURYSM. THERE IS THEREFORE A RISK OF RUPTURE.¿ SEVERAL QUERIES HAVE BEEN PLACED TO CLARIFY INFORMATION. ADDITIONAL INFORMATION RECEIVED 23FEB2017: NEW DATE OF ONE-MONTH FOLLOW-UP: (B)(6) 2016. ADDITIONAL INFORMATION RECEIVED 21MAR2017: THE SITE HAS NOW CHANGED THE INFORMATION THAT THE OBSERVATION OF AN ENDOLEAK TYPE 1B AT ONE-MONTH FOLLOW-UP WAS PRESENT AT PREVIOUS FILM READ. NO ADDITIONAL TECHNICAL OBSERVATIONS WERE NOTED. PATIENT OUTCOME: ON (B)(6) 2016 (10 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO SERIOUS ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PATIENT. ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED FOR A SECONDARY INTERVENTION TO TREAT THE TYPE IB ENDOLEAK. ENDOVASCULAR PLACEMENT OF A FENESTRATED ENDOPROSTHESIS WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346454 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | 10827002346618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Life Threatening| R |