ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION
Report
- Report Number
- 3002808486-2016-01228
- Event Type
- Injury
- Date Received
- October 13, 2016
- Date of Event
- September 20, 2016
- Report Date
- September 29, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002443454
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS PR WAS RE-OPENED DUE TO ADDITIONAL INFORMATION PROVIDED IN THE DESCRIPTION OF EVENT: THE ADDITIONAL INFORMATION DOES NOT CHANGE THE PREVIOUS CONCLUSION OR RISK ASSESSMENT OF THE COMPLAINT INVESTIGATION. IT IS STILL NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT, AS NO IMAGING IS AVAILABLE. BASED ON THE INFORMATION IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT, AS NO IMAGING WAS AVAILABLE. AS PER IFU, ENDOLEAK IS A KNOWN POTENTIAL EFFECT AND CAN, AMONG OTHERS, BE DUE TO: PROXIMAL AND DISTAL FIXATION SITES WITH A LENGTH OF LESS THAN 20 MM. CIRCUMFERENTIAL THROMBUS AND/OR CALCIFICATION AT THE FIXATION SITES. LESS THAN THE REQUIRED 2 STENTS (~50 MM) OF OVERLAP BETWEEN DEVICES. SIZING OUTSIDE THE SIZING CHART. NONE OF THESE FACTORS CAN BE RULED OUT WITHOUT IMAGING. PATIENTS WITH SPECIFIC CLINICAL FINDINGS, INCLUDING ENDOLEAKS, SHOULD RECEIVE ENHANCED FOLLOWUP. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
(B)(4). DEVICE SIMILAR TO DEVICE UNDER 510(K) P070016. B)(4). INVESTIGATION IS STILL IN PROGRESS.
(B)(4). DEVICE SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INFORMATION IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT, AS NO IMAGES WAS AVAILABLE. AS PER IFU, ENDOLEAK IS A KNOWN POTENTIAL EFFECT AND CAN, AMONG OTHERS, BE DUE TO: PROXIMAL AND DISTAL FIXATION SITES WITH A LENGTH OF LESS THAN 20 MM; CIRCUMFERENTIAL THROMBUS AND/OR CALCIFICATION AT THE FIXATION SITES; LESS THAN THE REQUIRED 2 STENTS (~50 MM) OF OVERLAP BETWEEN DEVICES; SIZING OUTSIDE THE SIZING CHART. NONE OF THESE FACTORS CAN BE RULED OUT WITHOUT PROVIDED IMAGES. PATIENTS WITH SPECIFIC CLINICAL FINDINGS, INCLUDING ENDOLEAKS, SHOULD RECEIVE ENHANCED FOLLOW UP. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
ADDITIONAL INFORMATION WITH CORRECTION 06OCT2017: (B)(6) 2016: 1YEAR FOLLOW UP CT ANGIO CONFIRMED RE-ENTRY AT THE CELIAC ARTERY.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2015: A FEMALE PATIENT UNDERWENT TEVAR WITH ZTEG-2PT-34-197-PF-D/ E3334269 IN THE PROXIMAL SITE AND ESBE-30-80-T-PF-D/ E3302841 IN THE DISTAL SITE. ON (B)(6) 2016: 1 YEAR F/U CT ANGIO CONFIRMED DISTAL TYPE I ENTRYFLOW. PATIENT OUTCOME: NO PROBLEMATIC SYMPTOMS DUE TO THIS EVENT HAS BEEN REPORTED.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2015: A FEMALE PATIENT UNDERWENT TEVAR WITH ZTEG-2PT-34-197-PF-D/ E3334269 IN THE PROXIMAL SITE AND ESBE-30-80-T-PF-D/ E3302841 IN THE DISTAL SITE. ON (B)(6) 2016: 1YEAR F/U CT ANGIO CONFIRMED DISTAL TYPE I ENTRYFLOW. PATIENT OUTCOME: NO PROBLEMATIC SYMPTOMS DUE TO THIS EVENT HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 676520 | ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | 10827002443454 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Life Threatening |