ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
Report
- Report Number
- 3002808486-2018-00920
- Event Type
- Injury
- Date Received
- August 16, 2018
- Date of Event
- November 9, 2017
- Report Date
- December 14, 2020
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002236131
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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). INVESTIGATION SUBMITTED 07DEC2018 IS STILL VALID AND THE NEW INFORMATION WILL BE HANDLED IN (B)(4) (MANUFACTURER REF. NUMBER (B)(4)) AND (B)(4) (MANUFACTURER REF. NUMBER (B)(4)). 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE OCCURRENCE OF THE TYPE III ENDOLEAK BETWEEN THE ZTEG-2PT (COMPLAINT DEVICE) AND ZTA-PT WAS NOTED IN THE IMAGING REVIEW FOR (B)(4) (RELATED COMPLAINT). ACCORDING TO THE REPORTED INFORMATION, THE PATIENT WAS DISCHARGED 19 DAYS POST-PROCEDURE. NO ADVERSE EFFECTS OR SECONDARY INTERVENTIONS RELATED TO TYPE 3A ENDOLEAK HAVE BEEN REPORTED IN THE COMPLAINT FILE. ACCORDING TO ADDITIONAL INFORMATION, THE PATIENT HAD A CT SCAN 196 DAYS AFTER THE PROCEDURE ((B)(6) 2018), THIS CT IMAGING HAS BEEN REQUESTED, BUT HAS NOT BEEN AVAILABLE FOR THE INVESTIGATION. SINGLE IMAGES FROM ANGIOGRAPHIC RUNS AT IMPLANTATION AND A ONE DAY POST IMPLANTATION CTA WERE PROVIDED FOR IMAGING REVIEW. IN THE IMAGING REVIEW, A TYPE 3A ENDOLEAK BETWEEN THE ZTEG AND ZTA DEVICES WAS NOTED FROM ONE DAY POST-IMPLANTATION CTA IMAGING. IT WAS NOTED IN THE REVIEW, THAT IMAGES FROM COMPLETION ANGIOGRAMS WERE INSUFFICIENT TO DEMONSTRATE THE LEAK. IT IS STATED IN THE IMAGING REVIEW, "THE ZTA-PT AND ZTEG-2PT ENDOLEAK WAS LIKELY THE RESULT OF PLEATING BETWEEN THE ZTEG-2PT SEALING STENT AND THE ZTA-PT. ALTHOUGH OVERLAP WAS THREE STENT LENGTHS, ACUTE, GREATER THAN 90 DEGREES AORTIC ANGULATION LIMITED THE ZTEG-2PT SEAL INSIDE THE ZTA-PT TO THE LENGTH OF THE ZTEG SECOND MAINBODY STENT". THE IMAGING REVIEWING PHYSICIAN NOTED IN THE IMAGING REVIEW THAT: " THROMBUS SHOULD EVENTUALLY SEAL THESE PLEATS". WHILE IT WAS NOTED IN THE IMAGING REVIEW THAT THE ENDOLEAK WAS LIKELY THE RESULT OF PLEATING BETWEEN THE ZTEG-2PT SEALING STENT AND THE ZTA-PT, IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF THE PLEATING OR DETERMINE THE ROOT CAUSE FOR THE CURRENT EVENT. ENDOLEAK IS LISTED IN THE IFU AS A POTENTIAL ADVERSE EVENT. THE IFU RECOMMENDS THAT NO LOCALIZED ANGULATION SHOULD BE LARGER THAN 45 DEGREES. ADDITIONAL ENDOLEAKS WERE NOTED FROM THE IMAGING REVIEW FOR (B)(4) AND ARE ADDRESSED IN SEPARATE COMPLAINTS. (B)(4) ADDRESSES THE OTHER DEVICE, ZTA-PT, INVOLVED IN THE CURRENT COMPONENT/COMPONENT ENDOLEAK. WCE WILL REOPEN THE INVESTIGATION OF THIS COMPLAINT IF FURTHER INFORMATION BECOMES AVAILABLE. NO EVIDENCE TO SUGGEST THAT THE PRODUCT 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.
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.
DESCRIPTION OF EVENT ACCORDING TO STUDY: (B)(4) WAS OPENED TO COVER COMPONENT/COMPONENT TYPE 3A ENDOLEAK BETWEEN ZTA-PT-44-40-179 AND ZTEG-2PT-42-32-165-PF. ON (B)(6) 2017 THE PATIENT RECEIVED THE FOLLOWING DEVICES: ZTA-PT-44-40-179 (LOT #E3601003) ((B)(4), BFARM REF# (B)(4)); TBRANCH-34-18-202 (LOT #E3601459) ((B)(4), BFARM REF# (B)(4)); ZTEG-2PT-42-32-165-PF (LOT #E3623804) ((B)(4) AND (B)(4)); UNIBODY-22-132 (LOT #A1000126) DISTAL BODY ; ZSLE-16-74-ZT (LOT #6384706) RIGHT ILIAC LEG GRAFT; ZSLE-20-74-ZT (LOT #6666996) LEFT ILIAC LEG GRAFT. ON THE COMPLETION ANGIOGRAM, THE DEVICES WERE PATENT WITH NO DEVICE INTEGRITY ISSUES. A TYPE IV ENDOLEAK WAS NOTED. ADDITIONAL INFORMATION RECEIVED ON 06FEB2018: THE NEXT DAY ((B)(6) 2017), THE POST-PROCEDURE FOLLOW-UP CT WAS PERFORMED. A TYPE II ENDOLEAK WAS NOTED. NO TYPE IV ENDOLEAK WAS NOTED. THE DEVICES WERE PATENT WITH NO DEVICE INTEGRITY ISSUES ((B)(4)). ADDITIONAL INFORMATION RECEIVED ON 18APR2018: "THE TYPE IV ENDOLEAK OBSERVED WAS NOT RELATED TO THE ZTA- DEVICE BUT FOR EITHER THE TRANCH- OR THE UNIBODY" ((B)(4)). ADDITIONAL INFORMATION RECEIVED 23JUL2018 FROM IMAGING REVIEW: "THE ZTA-PT AND ZTEG-2PT TYPE 3A ENDOLEAK WAS LIKELY THE RESULT OF PLEATING BETWEEN THE ZTEG-2PT SEALING STENT AND THE ZTA-PT. ALTHOUGH OVERLAP WAS TREE STENT LENGTHS, ACUTE, GREATER THAN 90 DEGREES AORTIC ANGULATION LIMITED THE ZTEG-2PT SEAL INSIDE THE ZTA-PT TO THE LENGTH OF THE ZTEG SECOND MAINBODY STENT ((B)(4))".
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.
ADDITIONAL INFORMATION RECEIVED (B)(6) 2019: LISTED IN FINDINGS BELOW 6-MONTH POSTOP CT STUDY: ¿A ZTEG THORACIC GRAFT OVERLAPS 53 MM WITH THE DISTAL ZTA GRAFT AND EXTENDS TO THE DISTAL THORACIC AORTA. THERE IS MODERATE TORTUOSITY ADJACENT TO THE OVERLAP SEGMENT BUT NO ENDOLEAK IS SEEN HERE.¿ ¿THE MAXIMUM TAAA SAC DIAMETER IS 112 X 90 MM. NO CLEAR ENDOLEAK IS SEEN WITHIN THE SAC. THERE IS AN AREA OF MILD ENHANCEMENT IN THE MID SAC, BUT THIS APPEARS CONSISTENT ON NON-CONTRAST IMAGING AS WELL, SO IS UNLIKELY TO BE AN ENDOLEAK.¿ LISTED IN FINDINGS BELOW 18-MONTH POSTOP CT STUDY: ¿THERE IS SIGNIFICANT 74-DEGREE ANGULATION AT THE OVERLAPS SEGMENT BETWEEN THE ZTA AND ZTEG GRAFTS. THE ZTEG GRAFT APPEARS PATENT WITH NO EVIDENCE OF ENDOLEAK AT THE OVERLAP JUNCTION.¿ ¿THE MAXIMUM TAAA SAC DIAMETER IS 101 X 80 MM. THERE IS NO CLEAR ENDOLEAK IDENTIFIED IN THE TAAA SAC.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 629527 | ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E3623804 | 10827002236131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Life Threatening |