ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Report
- Report Number
- 3002808486-2018-00788
- Event Type
- Death
- Date Received
- June 29, 2018
- Date of Event
- June 22, 2018
- Report Date
- November 12, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002346618
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. INVESTIGATION IS STILL IN PROGRESS.
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. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT STATES A PROCEDURE WHERE SEVERAL THORACIC PIECES WERE IMPLANTED (INCLUDING THE COMPLAINT DEVICE, ZTA-PT-46-42-233). THEN A WIRE WAS PLACED FROM THE AXILLARY TO THE FEMORAL ARTERY AND DURING ADVANCEMENT OF A 12F SHEATH (NOT A COOK DEVICE) THE PATIENT'S BLOOD PRESSURE DROPPED. AFTER 45 MIN REANIMATION THE PATIENT DIED. ADDITIONAL INFORMATION FROM THE PHYSICIAN STATES THAT THE PATIENT EXPERIENCED PAIN BEFORE THE PROCEDURE, WHICH WAS WHY THE PROCEDURE WAS PERFORMED AND THAT HE ASSUMED THE RUPTURE WAS PRESENT BEFORE THE PROCEDURE. AS PER CLINICAL ASSESSMENT OF THIS EVENT, THE TEVAR WAS PERFORMED AS AN EMERGENCY PROCEDURE ON SUSPICION OF RUPTURE OF THE ANEURYSM. THE DEPLOYMENT OF THE ENDOGRAFT WENT UNEVENTFUL, BUT AT THE NEXT STAGE UPON ADVANCEMENT OF A SHEATH FROM THE AXILLARY ARTERY, BLOOD PRESSURE SUDDENLY DROPPED. DESPITE RESUSCITATION ATTEMPTS FOR 45 MIN THE PATIENT DIED. THE DRAMATIC EVENT MAY HAVE BEEN CAUSED BY A COMPLETE AORTIC RUPTURE AS SUSPECTED BY THE PHYSICIAN, OR ALTERNATIVELY BY A RETROGRADE TYPE A AORTIC DISSECTION, WHICH CAN EXHIBIT AN EQUALLY DRAMATIC COURSE, THE LATTER SUGGESTION BEING SPECULATIVE ONLY. THUS, THIS UNFORTUNATE EVENT IS ASSESSED TO BE PROCEDURE- AND PATIENT-RELATED, PRIMARILY DUE TO THE PATIENT¿S OVERALL AORTIC PATHOLOGY. BASED ON THE PROVIDED INFORMATION, THE LIKELY CAUSE FOR THE PATIENT DEATH IS PROCEDURE- AND PATIENT-RELATED. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
ADDITIONAL INFORMATION RECEIVED 04JUL2018: "IT IS SUGGESTED THAT THE DEATH WASN'T RELATED TO THE ZTA GRAFT, BECAUSE THEY DID IMPLANT IT FIRST AND THERE WAS NO REACTION TO THIS. IT HAPPENED WHEN ADVANCING THE 12F SHEATH FROM ABOVE". ADDITIONAL INFORMATION RECEIVED 16JUL2018: "PHYSICIAN ASSUMED THAT THE PATIENT HAD A CONTAINED RUPTURE BEFORE THE PROCEDURE, BECAUSE OF PAIN. THEREFORE WE DID THE PROCEDURE. WHY HE DIED DURING PROCEDURE, IS UNKNOWN".
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THORACIC PIECES IN PLACE, TBRANCH RELEASED, EVERYTHING WENT FINE. THEN WE DID USE A WIRE (TERUMO) FROM THE AXILLARY TO THE FEMORAL ARTERY AS GUIDANCE FOR THE 12F SHEATH TO ACCESS THE BRANCHES. DURING ADVANCING OF THE SHEATH THE PATIENT SUDDENLY DIDN'T HAD ANY BLOOD PRESSURE ANY MORE. AFTER 45 MINUTES REANIMATION THE PATIENT WAS DEAD. WE COULDN'T SAY WHAT HAD HAPPENED. POLICE AND RELATIVES DON'T WANT AN AUTOPSY, SO WE'LL NEVER KNOW WHAT HAPPENED. DOCTOR ASSUMED, THAT THE ANEURYSM DID RUPTURE." PATIENT OUTCOME: PATIENT IS DECEASED.
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 |
|---|---|---|---|---|---|---|---|
| 495508 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3721191 | 10827002346618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |