ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2018-00862
- Event Type
- Injury
- Date Received
- August 8, 2018
- Date of Event
- July 13, 2018
- Report Date
- February 5, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002449555
- 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) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. (B)(4). H11) CORRECTED DATA: B5) DESCRIPTION OF EVENT. DEVICE RPNS HAVE BEEN UPDATED. INVESTIGATION IS STILL IN PROGRESS. 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). MANUFACTURERS REF# (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(6). REGISTRATION NO.: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT FOCUSSES ON 72-YEAR-OLD FEMALE PATIENT WHO UNDERWENT TAA REPAIR. ZTA-P-34-209-W1 AND ZTA-D-34-190-W1 WERE PLACED WITH APPROXIMATELY 3 STENTS OVERLAPPING. THE OVERLAP WAS SLIGHTLY SHORT BECAUSE THE PHYSICIAN GAVE PRIORITY TO THE DISTAL LANDING POINT. AFTER BALLOONING WAS PERFORMED, ENDOLEAK THAT SEEMED TO BE TYPE IV AND/OR TYPE III WAS CONFIRMED, SO ADDITIONAL BALLOONING WAS PERFORMED. HOWEVER, THE ENDOLEAK WAS NOT SOLVED, SO THE PHYSICIAN DECIDED TO PLACE A THIRD STENT GRAFT TO COVER THE JUNCTION. ADVANCEMENT DIFFICULTY WAS EXPERIENCED WITH THE THIRD DEVICE. THIS IS ADDRESSED IN A SEPARATE COMPLAINT. ZTA-DE-34-112-W1 WAS USED INSTEAD AND THE STENT GRAFT WAS PLACED SUCCESSFULLY. IT WAS THEN CONFIRMED THAT THE ENDOLEAK WAS SOLVED AND COMPLETED THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS DUE TO THIS OCCURRENCE THE INVESTIGATION OF THIS EVENT WAS ONLY BASED ON THE PROVIDED INFORMATION. NO IMAGING WAS PROVIDED. AS PER PERFORMED CLINICAL ASSESSMENT OF THIS EVENT, "FROM THE DESCRIPTION OF THE LENGTH OF THE TREATED AREA AND THE FACT THAT THE COMPONENTS USED INITIALLY ARE THE LONGEST AVAILABLE, IT IS PLAUSIBLE THAT THE WIDESPREAD PATHOLOGY CONTRIBUTED TO THE INABILITY OF THE OVERLAPPING COMPONENTS TO SEAL OF THE ANEURYSM. THE PHYSICIAN¿S DECISION TO PRIORITIZE THE DISTAL LANDING ZONE OVER COMPONENT OVERLAP SEEMS REASONABLE, AND THE ENDOLEAK WAS EVENTUALLY MANAGED SATISFACTORY BY THE DISTAL EXTENSION, WHICH IS EXACTLY IN ACCORDANCE WITH ITS¿ INTENDED USE. THE PHYSICIAN FOLLOWED THE RECOMMENDED STEPS DURING THE PROCEDURE. THE ATTEMPT TO REPAIR THE ENDOLEAK WITH A PROXIMAL COMPONENT FAILED, AND INSTEAD THE OVERLAP WAS REINFORCED WITH A DISTAL EXTENSION AS PER THE IFU. IN SUMMARY, PATIENT PATHOLOGY MAY HAVE CONTRIBUTED TO THE TYPE IIIB ENDOLEAK. IT IS UNCLEAR WHAT ¿APPROX. 3 STENT OVERLAP¿ MEANS, BUT IT IS ASSUMED THAT IT IS LESS THAN 3 STENTS AND THEREFORE LESS THAN RECOMMENDED, IN WHICH CASE THERE IS HIGHER RISK OF TYPE III ENDOLEAK." THE ENDOLEAK WAS RESOLVED BY PLACEMENT OF AN ADDITIONAL STENT GRAFT AT THE OVERLAP REGION, THIS EVENT IS LIKELY TYPE IIIB ENDOLEAK AND NOT TYPE IV ENDOLEAK. 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 INITIAL REPORTER: A (B)(6) FEMALE PATIENT UNDERWENT TAA REPAIR. THE ACCESS VESSEL WAS PARTIALLY NARROWED AND THE AORTA WAS PARTIALLY TORTUOUS, BUT THE PHYSICIAN DETERMINED THAT DELIVERY SYSTEMS WOULD BE ADVANCED. THE TREATMENT AREA WAS LONG. ZTA-P-34-209-W1 WAS PLACED FROM RIGHT BELOW THE LEFT SUBCLAVIAN ARTERY, AND THEN ZTA-D-34-190-W1 WAS PLACED WITH APPROX 3 STENS OVERLAPPING. THE OVERLAP WAS SLIGHTLY SHORT BECAUSE THE PHYSICIAN GAVE PRIORITY TO THE DISTAL LANDING POINT. AFTER BALLOONING WAS PERFORMED, ENDOLEAK THAT WAS SEEMED TO BE TYPE IV AND/OR TYPE III WAS CONFIRMED, SO ADDITIONAL BALLOONING WAS PERFORMED. HOWEVER, THE ENDOLEAK WAS NOT SOLVED, SO THE PHYSICIAN DECIDED TO PLACE ZTA-P-34-161-W1 TO COVER THE JUNCTION AND AS MANY PART OF ZTA-P-34-209-W1. ((B)(4)) HE INSERTED THE DELIVERY SYSTEM OF ZTA-P-34-209-W1 FROM THE RIGHT FEMORAL BUT COULD NOT ADVANCE TO THE TARGET SITE. IT COULD BE DUE TO INTERFERENCE OF PREVIOUSLY PLACED STENT GRAFTS. HE TRIED TO ADVANCE IT FROM THE LEFT FEMORAL BUT FAILED. HE FELT STRONG RESISTANCE AS IF IT GOT CAUGHT WITH SOMETHING, SO HE REMOVED IT FROM THE PATIENT AND FOUND THE DEVICE TIP WAS FRAYED. HE GAVE UP ON USING THIS DEVICE TO AVOID THE RISK OF VESSEL DAMAGE. ((B)(4)) ZTA-DE-34-112-W1 WAS USED INSTEAD AND THE STENT GRAFT WAS PLACED SUCCESSFULLY TO COVER THE JUNCTION AND AS MANY PART OF ZTA-P-34-209-W1. HE CONFIRMED THAT THE ENDOLEAK WAS SOLVED AND COMPLETED THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS DUE TO THIS OCCURRENCE AND IS DOING FINE AFTER THE PROCEDURE.
UPDATED DEVICE RPN IN DESCRIPTION OF EVENT: A 72 YEAR OLD FEMALE PATIENT UNDERWENT TAA REPAIR. THE ACCESS VESSEL WAS PARTIALLY NARROWED AND THE AORTA WAS PARTIALLY TORTUOUS, BUT THE PHYSICIAN DETERMINED THAT DELIVERY SYSTEMS WOULD BE ADVANCED. THE TREATMENT AREA WAS LONG. ZTA-P-34-209-W1 WAS PLACED FROM RIGHT BELOW THE LEFT SUBCLAVIAN ARTERY, AND THEN ZTA-D-34-190-W1 WAS PLACED WITH APPROX 3 STENTS OVERLAPPING. THE OVERLAP WAS SLIGHTLY SHORT BECAUSE THE PHYSICIAN GAVE PRIORITY TO THE DISTAL LANDING POINT. AFTER BALLOONING WAS PERFORMED, ENDOLEAK THAT WAS SEEMED TO BE TYPE IV AND/OR TYPE III WAS CONFIRMED, SO ADDITIONAL BALLOONING WAS PERFORMED. HOWEVER, THE ENDOLEAK WAS NOT SOLVED, SO THE PHYSICIAN DECIDED TO PLACE ZTA-P-34-161-W1 TO COVER THE JUNCTION AND AS MANY PART OF ZTA-P-34-209-W1. (B)(4). HE INSERTED THE DELIVERY SYSTEM OF ZTA-P-34-161-W1 FROM THE RIGHT FEMORAL BUT COULD NOT ADVANCE TO THE TARGET SITE. IT COULD BE DUE TO INTERFERENCE OF PREVIOUSLY PLACED STENT GRAFTS. HE TRIED TO ADVANCE IT FROM THE LEFT FEMORAL BUT FAILED. HE FELT STRONG RESISTANCE AS IF IT GOT CAUGHT WITH SOMETHING, SO HE REMOVED IT FROM THE PATIENT AND FOUND THE DEVICE TIP WAS FRAYED. HE GAVE UP ON USING THIS DEVICE TO AVOID THE RISK OF VESSEL DAMAGE. (B)(4). ZTA-DE-34-112-W1 WAS USED INSTEAD AND THE STENT GRAFT WAS PLACED SUCCESSFULLY TO COVER THE JUNCTION AND AS MANY PART OF ZTA-P-34-209-W1. HE CONFIRMED THAT THE ENDOLEAK WAS SOLVED AND COMPLETED THE PROCEDURE.
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 |
|---|---|---|---|---|---|---|---|
| 606933 | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3708172 | 10827002449555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Life Threatening |