ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2022-00145
- Event Type
- Injury
- Date Received
- February 25, 2022
- Report Date
- May 18, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002347097
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT IS REPORTED THAT ZENITH PLANNING ASIA PACIFIC WAS REVIEWING A COMPUTED TOMOGRAPHY (CT) SENT IN FOR EVALUATION OF POSSIBLE TREATMENTS FOR PSEUDOANEURYSM. IT WAS NOTICED THAT THE IN-SITU COOK ALPHA THORACIC GRAFT (ZTA-P-40-217, LOT E3604421) HAD A DEFORMED BARE STENT THAT APPEARED TO BE HOLDING THE PROXIMAL GRAFT EDGE OFF THE AORTIC WALL & POTENTIALLY CAUSING A PROXIMAL ENDOLEAK. THE 79-YEAR-OLD FEMALE PATIENT REPORTEDLY HAD THE ALPHA GRAFT IMPLANTED IN 2017 ALONG WITH A ZDES-46-120. THE CURRENT DOCTOR DID NOT IMPLANT THAT GRAFT, BUT PROVIDED THAT THE GRAFT HAD ALWAYS HAD A PROXIMAL LEAK FROM IMPLANTATION. THE PATIENT IS CURRENTLY TOO ILL FOR FURTHER TREATMENT OF THE ENDOLEAK, AND WHETHER THIS IS THE RESULT OF THE BENT STENT & ENDOLEAK IS UNKNOWN. AS PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT NOW HAS A PSEUDO ANEURYSM AT THE JUNCTION BETWEEN THE GRAFT FROM ANOTHER MANUFACTURE AND ALPHA GRAFT AND IT APPEARS TO BE INFECTED. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME. THE PRODUCT WAS NOT RETURNED. A CTA PERFORMED (B)(6) 2022 WAS PROVIDED AND UNDERWENT CLINICAL REVIEW FOR THE INVESTIGATION. AS PER FINDINGS IN THE IMAGING REVIEW: THE CTA CONFIRMS A PRIOR MEDIAN STERNOTOMY AND GRAFT FROM ANOTHER MANUFACTURE WITH BRANCH REIMPLANTATION OF THE IA AND LEFT CCA. THE TYPICAL ROLLED ANASTOMOTIC APPEARANCE IS ABSENT. SUBTLE FOLDS JUST DOWNSTREAM THE SINOTUBULAR JUNCTION SUGGEST GRAFT MATERIAL JUST BEYOND THE SINOTUBULAR JUNCTION. HOWEVER, PARTIAL ANASTOMOTIC RING AT THE ARCH VESSEL BRANCH ORIGIN SUGGESTS THAT THE GRAFT FROM ANOTHER MANUFACTURE MAY HAVE ONLY EXTENDED TO IA AND THAT THE NATIVE ASCENDING AORTIC ARCH AND PROXIMAL IA WERE STILL PRESENT. THE DISTAL EDGE OF THE GRAFT FROM ANOTHER MANUFACTURE WAS ALSO UNCLEAR. THE ABRUPT AORTIC LUMEN DILATION JUST BEYOND THE IA BRANCH COULD REPRESENT THE END OF THE GRAFT FROM ANOTHER MANUFACTURE HOWEVER THE TYPICAL ANASTOMOTIC ROLL IS ABSENT. A LEFT ANTERIOR ALPHA THORACIC BARE STENT WAS PERCHED ON THE AORTIC WALL. THE MORE INFERIOR APICES WERE FLARED INTO AN EXPANDED SEGMENT OF AORTA DISTAL THE PRESUMPTIVE GRAFT FROM ANOTHER MANUFACTURE TRAILING EDGE. THE DILATED AORTIC SEGMENT WAS CONSISTENT WITH A PSEUDOANEURYSM. DENSITIES AROUND ITS PERIPHERY SUGGEST PIECES OF AN ANASTOMOTIC RING. THE PROXIMAL ALPHA STENT SEGMENTS WERE CROWDED PARTICULARLY ON THE INNER AORTIC CURVATURE. ALTHOUGH THIS IS NORMAL ALONG INNER AORTIC CURVATURE, SUBJECTIVELY THE CROWDING WAS GREATER THAN THE CURVE TYPICALLY REQUIRES. THIS SUGGESTS DISTAL SETTLING OF THE PROXIMAL ZTA-P. ENDOLEAK AROUND THE PROXIMAL ZTA-P DID NOT COMMUNICATE WITH DISTAL FALSE LUMEN PERFUSION. INFLAMMATORY CHANGES IN THE RIGHT ABDOMEN AND FLUID IN THE PELVIS INDICATE INTRAABDOMINAL INFECTION. THE MOST LIKELY ETIOLOGIES WERE A RUPTURED APPENDIX OR RUPTURED SIGMOID DIVERTICULUM". THE IMPRESSION OF THE IMAGING REVIEWER IS "THE PERCHED APEX MAY HAVE BEEN THE RESULT OF THE PSEUDOANEURYSM". ALSO "THE PSEUDOANEURYSM COULD HAVE DEVELOPED FROM SECONDARY INFECTION, A PERSISTENT TYPE 1A ENDOLEAK, THE PERCHED STENT APEX, OR A COMBINATION OF THESE. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. AS PER IMAGING REVIEW , IT IS INDICATED THAT THE INITIAL PATHOLOGY WAS A LIKELY TYPE B DISSECTION WITH ARCH INVOLVEMENT. AS PER INSTRUCTIONS FOR USE (IFU) : THE SAFETY AND EFFECTIVENESS OF THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT AND ANCILLARY COMPONENTS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: TREATMENT OF DISSECTION IS SUBSEQUENTLY CONSIDERED OFF-LABEL USE. IMPLANTATION OF AN ALPHA DEVICE IN COMBINATION WITH A ZDES DEVICE IS USE OUTSIDE OF THE IFU . "THE SAFETY AND EFFECTIVENESS OF THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT AND ANCILLARY COMPONENTS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS:¿ DISSECTIONS." AS PROCEDURAL-/POST PROCEDURE IMAGING OR INFORMATION REGARDING THE INITIAL PROCEDURE WAS NOT PROVIDED, IT HAS NOT BEEN POSSIBLE TO DETERMINE WHETHER THE ALPHA DEVICE WAS IMPLANTED INSIDE THE GRAFT FROM ANOTHER MANUFACTURE, WHICH WOULD ALSO BE CONSIDERED OFF-LABEL USE. ADDITIONAL INFORMATION INCLUDING INFORMATION ON INFECTION AND PATIENT OUTCOME, AS WELL AS PROCEDURAL AND POST-PROCEDURE IMAGING FROM 2017 AND FOLLOW-UP IMAGING HAS BEEN REQUESTED SEVERAL TIMES BUT NOT PROVIDED FOR THE INVESTIGATION. BASED ON THE LIMITED INFORMATION PROVIDED AND REVIEW OF IMAGING IT HAS NOT BEEN POSSIBLE TO ESTABLISH AN EXACT CAUSE OF THE REPORTED EVENT, AND THE SEQUENCE OF HOW THE EVENTS UNFOLDED. IT CAN NOT BE EXCLUDED THAT THE INITIAL CONDITIONS FOR IMPLANTATION, INCLUDING MORPHOLOGY AND DIMENSIONS OF LANDING ZONE, DISSECTION AND POTENTIAL OVERLAP WITH GRAFT FROM ANOTHER MANUFACTURE CONTRIBUTED TO THE TYPE 1 ENDOLEAK AND SUBSEQUENT EFFECTS. 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 OG EVENT ACCORDING TO INITIAL REPORTER: WHILE ZENITH PLANNING APAC, VASCULAR DIVISION WAS REVIEWING THE CT SCAN SENT IN FOR EVALUATION OF ANY POSSIBLE TREATMENTS FOR PSEUDOANURYSM IN THE ARCH, THEY NOTICED THAT THE INSITU COOK ALPHA THORACIC GRAFT HAD A DEFORMED BARE STENT THAT APPEARED TO BE HOLDING THE PROXIMAL GRAFT EDGE OFF THE AORTIC WALL & POTENTIALLY CAUSING A PROXIMAL ENDOLEAK. THIS WAS DISCUSSED WITH PLANNING TEAM, REP & DOCTOR. THEY HAVE INFORMED REP & DOCTOR THAT A COMPLAINT WILL BE INITIATED FOR THE DEFORMED PROXIMAL BARE STENT. CURRENT DOCTOR, DID NOT IMPLANT THE GRAFT.
DESCRIPTION OG EVENT ACCORDING TO INITIAL REPORTER: WHILE ZENITH PLANNING APAC, VASCULAR DIVISION WAS REVIEWING THE CT SCAN SENT IN FOR EVALUATION OF ANY POSSIBLE TREATMENTS FOR PSEUDOANURYSM IN THE ARCH, THEY NOTICED THAT THE INSITU COOK ALPHA THORACIC GRAFT HAD A DEFORMED BARE STENT THAT APPEARED TO BE HOLDING THE PROXIMAL GRAFT EDGE OFF THE AORTIC WALL & POTENTIALLY CAUSING A PROXIMAL ENDOLEAK. THIS WAS DISCUSSED WITH PLANNING TEAM, REP & DOCTOR. THEY HAVE INFORMED REP & DOCTOR THAT A COMPLAINT WILL BE INITIATED FOR THE DEFORMED PROXIMAL BARE STENT. CURRENT DOCTOR, DID NOT IMPLANT THE GRAFT.
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 |
|---|---|---|---|---|---|---|---|
| 1682499 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3604421 | 10827002347097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female |