ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2023-00102
- Event Type
- Death
- Date Received
- April 19, 2023
- Date of Event
- January 2, 2022
- Report Date
- July 4, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002242699
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A 73-YEAR-OLD PATIENT WITH MULTIPLE CO-MORBIDITIES WAS TREATED FOR A CONTAINED RUPTURED PARARENAL ABDOMINAL AORTIC ANEURYSM (PRAAA) WERE AN IMPROVISED FENESTRATED ZDEG-P-30-142-PF (COMPLAINT DEVICE) WITH 2 FENESTRATIONS FOR CELIAC TRUNK (CT) AND SUPERIOR MESENTERIC ARTERY (SMA) WAS INSERTED. FURTHER, THE CT WINDOW WAS STENTED WITH AN 8X32 ADVENTA V12 AND THE SMA WINDOW WAS LEFT UNSTENTED AFTER SEVERAL ATTEMPTS. SMA SEEMED PERFUSED BY THE CT VIA THE PANCREATICO-DUODENAL ARCADE. COMPLAINT DEVICE COVERED RENAL ARTERIES. ZIMB-32-98, RIGHT-SIDE ZISL-11-77, LEFT-SIDE ZISL-16-93 AND RIGHT-SIDE HYPOGASTRIC EMBOLIZATION WAS ALSO PLACED DURING SURGERY. ALL DEVICES IMPLANTED PERFORMED AS INTENDED. 0 DAYS POST-PROCEDURE (EVENING): A COMPUTED TOMOGRAPHY SHOWED TWO ENDOLEAKS ON THE TYPE 2 STENT, SITUATED BELOW THE RENAL ARTERIES AND AT THE LEVEL OF THE ILIAC BIFURCATION WITH OCCLUSION OF THE SUPERIOR MESENTERIC ARTERY, WHICH THEN BECAME PERMEABLE BUT WITH NO SIGNS OF DIGESTIVE DISCOMFORT. (ENDOLEAKS ARE ASSESSED RELATED TO ZIMB/ZISL DEVICES AND WILL BE HANDLED IN RELATED COMPLAINT). 2 DAYS POST-PROCEDURE: THE PATIENT PRESENTED WITH ABDOMINAL PAIN LEADING HIM TO RETURN TO THE SURGERY. WHEN OPENED THE INTESTINE WAS ISCHEMIC AND RESULTED IN PATIENT DEATH. THE SITE RELATED THE STUDY DEVICE TO THE ADVERSE EVENT DUE TO ¿FAILURE OF THE MESENTHERIC CATHETERIZATION¿. DEVICE WAS NOT RETURNED. PER CLINICAL ASSESSMENT, ¿GIVEN THAT THERE WAS A RUPTURE AND THE POOR CHANCE OF SURVIVAL WITHOUT ANY INTERVENTION, AS WELL AS THE PATIENT¿S DESIRE TO BE TREATED, THE DECISION WAS MADE TO PROCEED WITH AN ENDOVASCULAR PROCEDURE. OPEN SURGERY DID NOT APPEAR A REASONABLE PROPOSITION GIVEN THE CIRCUMSTANCES. IT WAS NOT POSSIBLE TO WAIT FOR A TAILOR-MADE STENT AND THE DECISION WAS MADE TO IMPROVISE A STENT.¿ FURTHER, ¿IT IS ASSESSED THAT THE BOWEL ISCHEMIA, AND RESULTING DEATH, ARE LIKELY RELATED TO THE FAILED CANNULATION OF THE SMA AND HENCE THE PROCEDURE (OUTSIDE INTENDED USE). IT IS NOT ASSESSED THAT THE DEVICE ITSELF WAS A FAULT DEVICE OR WAS THE CAUSE OF THE FAILURE.¿ REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. PER IFU, ¿THE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT WITH PRO-FORM AND THE Z-TRAK PLUS INTRODUCTION SYSTEM IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH SYMPTOMATIC DISSECTION OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR¿ AND FURTHER, ¿UNLESS MEDICALLY INDICATED, DO NOT DEPLOY THE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT WITH PRO-FORM IN A LOCATION THAT WILL OCCLUDE ARTERIES NECESSARY TO SUPPLY BLOOD FLOW TO ORGANS OR EXTREMITIES. DO NOT COVER SIGNIFICANT ARCH OR MESENTERIC ARTERIES (EXCEPTION MAY BE THE LEFT SUBCLAVIAN ARTERY) WITH THE ENDOPROSTHESIS. VESSEL OCCLUSION MAY OCCUR.¿ BASED ON THE PROVIDED INFORMATION, THE BOWEL ISCHEMIA WAS LIKELY CAUSED BY THE FAILURE OF CANNULATING THE SMA, WHICH ULTIMATELY RESULTED IN PATIENT DEATH. THE COMPLAINT DEVICE WAS USED OUTSIDE OF INTENDED USE, AS ZDEG IS INTENDED FOR DISSECTION IN DESCENDING THORACIC AORTA. FURTHER, DEVICE MODIFICATIONS ARE NOT SUPPORTED BY THE IFU NOR CLINICAL TESTING. 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 INITIAL REPORTER: TYPE IIIA-BOWEL ISCHEMIA REPORTED (B)(6) 2023 AS RELATED TO THE PROCEDURE AND RELATED TO THE DEVICE. PRIMARY INDICATION FOR IMPLANT WAS AORTIC ANEURYSM AND PRE-PROCEDURAL IMAGING INFORMATION WAS NOT PROVIDED AT THIS TIME. THE PROCEDURE WAS DONE PERCUTANEOUSLY WITH ACCESS SITE UNKNOWN. A BALLOON WAS USED FOR ENDOPROTHES IMPACTION WITH UNKNOWN LOCATION OF THE BALLOON AT THIS TIME. ONE STENT FROM ANOTHER MANUFACTURER, ONE COOK GRAFT, AND TWO COOK STENTS WERE IMPLANTED DURING THE PROCEDURE. THE PROXIMAL ZONE OF ZENITH DISSECTION ENDOVASCULAR GRAFT HAS NOT BEEN IDENTIFIED AT THIS TIME. DURING THE STUDY PROCEDURE A HYPOGRASTRIC ARTERY EMBOLIZATION WAS ALSO DONE BEFORE STUDY DEVICE DEPLOYMENT. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND NO SEPARATION OF DEVICES. THE PROCEDURAL ANGIOGRAPHY SHOWED A PATENT STUDY DEVICE. THERE WAS NO ENDOLEAK PRESENT. NO SEPARATION OF DEVICES HAD OCCURRED OR ANY DEVICE INTEGRITY ISSUES. ALL DEVICES IMPLANTED PERFORMED AS INTENTED. (B)(6) 2021 (0 DAYS POST-PROCEDURE), A COMPUTED TOMOGRAPHY (CT) REVEALED A TYPE II ENDOLEAK. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. (B)(6) 2022 (TWO DAYS POST PROCEDURE), BOWEL ISCHEMIA WAS REPORTED AS AN ADVERSE EVENT. THERE WAS NO TREATMENT. THE SITE HAS RELATED IT TO THE STUDY DEVICE STATING ¿FAILURE OF THE MESENTHERIC CATHETERIZATION DURING THE SURGERY TO TREAT THE ANYERYSM.¿ THE SITE ALSO RELATED IT TO THE DEVICE STATED ¿THE FAILURE OF THE MESENTHERIC CATHETERIZATION. THE MESENTHERIC WAS OCCLUDED ON THE CONTROL CT, THEN PATENT WITHOUT DIGESTIVE PAIN. THE PATIENT PRESENTED WITH ABDOMINAL PAIN LEADING HIM TO RETURN TO THE SURGERY. WHEN OPENED THE INTESTINE WAS ISCHEMIC.¿ THIS EVENT LEAD TO THE PATIENTS DEATH. PATIENT OUTCOME: PATIENT DIED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION 25APR2023: THIS IS RELATED TO THE ZDEG DEVICE. APPARENTLY, ON THE SURGERY REPORT, THE ZDEG DEVICE WAS FENESTRATED WITH A THERMOCUTTER, ONE FOR THE CELIAC TRUNK AND THE OTHER FOR THE SUPERIOR MESENTERIC AORTA (SMA). THE DEVICE WAS THEN IMPLEMENTED BUT THE SMA FAILED TO BE CATHETERIZED/CANNULATED DURING THE SURGERY. SEVERAL ATTEMPTS WERE MADE BUT WITHOUT SUCCESS. THE SMA SEEMED PERFUSED BY THE TRUNCUS COELIACUS (TC) VIA THE PANCREATICO-DUODENAL ARCADE. THE PHYSICIAN ANSWERED THAT THIS WAS RELATED TO THE STUDY PROCEDURE, AS THE BOWEL ISCHEMIA WAS THE CONSEQUENCE OF THE SMA NOT BEING ABLE TO BE CATHETERIZED DURING THE SURGERY WHERE THE DEVICE WAS IMPLEMENTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1373595 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E4187472 | 10827002242699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Death |