ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2025-00162
- Event Type
- Injury
- Date Received
- July 29, 2025
- Date of Event
- January 12, 2019
- Report Date
- January 30, 2026
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER¿S REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: FROM A POST MARKET STUDY COOK BECAME AWARE OF A 65-YEAR-OLD FEMALE PATIENT UNDERWENT EMERGENCY THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) ON (B)(6) 2019 FOR A PENETRATING AORTIC ULCER WITH CONTAINED RUPTURE. A ZENITH ALPHA THORACIC PROXIMAL STENT-GRAFT (ZTA-P-34-161) WAS DEPLOYED FROM ZONE 1, COMPLETELY COVERING THE LEFT SUBCLAVIAN ARTERY; PROXIMAL SEALING LENGTH WAS REPORTED AS 15 MM. CONCOMITANT PROCEDURES INCLUDED A LEFT SUBCLAVIAN¿LEFT COMMON CAROTID BYPASS, EMBOLISATION OF THE LEFT SUBCLAVIAN ARTERY AND A CHIMNEY STENT. AFTER THE PROCEDURE THE PATIENT REPORTEDLY HAD NINE ADVERSE EVENTS AND TWO SECONDARY INTERVENTIONS. MOST ADVERSE EVENTS WERE ATTRIBUTED TO A PROLONGED HOSPITAL STAY OR THE FOLLOWING PROCEDURES RATHER THAN TO THE INITIAL PROCEDURE OR STUDY DEVICE. THREE COMPLAINTS WERE THEREFORE LOGGED: TYPE 1A ENDOLEAK (THIS COMPLAINT) TYPE 2 ENDOLEAK. THROMBUS IN STUDY DEVICE NOTED ON 1 MONTH POST-OP IMAGING. IN RELATION TO THE DESCRIPTION OF THE TYPE 1A ENDOLEAK IT IS STATED THAT THE ENDOLEAK IS ASSOCIATED WITH THE TREATED AORTIC DISEASE AND PROCEDURE AND IT IS ELABORATED THAT ¿CONCURRENT AORTITIS AND SEPSIS (STAPHYLOCOCCUS AUREUS, CANDIDA GUILLIERMONDII) CAUSED PYO-PERICARDIUM REQUIRING DRAINAGE. A PERICARDIAL PIGTAIL DRAIN HAD BEEN ATTEMPTED THE PREVIOUS DAY; SURGICAL DRAINAGE WAS ULTIMATELY NECESSARY.¿ BASED ON THE PROVIDED INFORMATION IT IS ASSUMED THAT THE PATIENT PRIOR TO THE STUDY PROCEDURE HAD CONCURRENT AORTITIS AND SEPSIS WITH STAPHYLOCOCCUS AUREUS AND CANDIDA GUILLIERMODII. INFORMATION RELATED TO THE TYPE 2 ENDOLEAK STATES THAT THIS WAS INITIALLY THOUGHT TO ORIGINATE FROM LEFT SUBCLAVIAN ARTERY (LSA) NOT FULLY EXCLUDED BY PLUGS WHY A COIL EMBOLIZATION WAS PERFORMED TO TREAT THE ENDOLEAK. THIS INTERVENTION WAS NOT SUCCESSFUL, WHY THE PATIENT UNDERWENT A OPEN AORTIC-ARCH RECONSTRUCTION ON (B)(6) 2019 TO TREAT BOTH THE TYPE 1A AND THE TYPE 2 ENDOLEAK. BOTH ENDOLEAKS WERE REPORTED TO BE PRESENT ON PROCEDURE IMAGING AND AGAIN ON IMAGING (B)(6) 2019. IN ADDITION TO THE ENDOLEAKS THROMBUS WAS ALSO SEEN ON THE IMAGING (B)(6) 2019. NO INTERVENTION FOR THE THROMBUS IS REPORTED. THE INFORMATION PROVIDED IS NOT CLEAR AND SOME DATES DO NOT ALIGN WITH THE REPORTED COURSE OF EVENTS, HOWEVER AS THE PATIENT IS DECEASED NO MORE INFORMATION IS AVAILABLE. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. THE DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT EVENT IS RELATED TO THE IMPLANTED STENT GRAFT. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE IFU/AND OR LABEL. THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE PRODUCT LABELING AND/OR INSTRUCTIONS, THEREFORE IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION. PER THE IFU THE SAFETY AND EFFECTIVENESS OF THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT AND ANCILLARY COMPONENTS HAVE NOT BEEN EVALUATED IN PATIENT POPULATIONS WITH AORTITIS OR INFLAMMATORY ANEURYSMS, MYCOTIC ANEURYSMS AND SYSTEMIC INFECTION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT AS DESCRIBED IN THE INSTRUCTION FOR USE. PER THE IFU ENDOLEAK IS A KNOWN ADVERSE EVENT. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSE FOR THE EVENT ARE THE USE OF THE DEVICE OUTSIDE OF THE INTENDED USE. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE 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.
MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: P140016. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
DESCRIPTION OF EVENT ACCORDING TO STUDY ((B)(6): ZENITH ALPHA THORACIC POST MARKET RETROSPECTIVE STUDY): ENDOLEAK TYPE 1A POST-PROCEDURE. ON (B)(6) 2019, THIS 65-YEAR-OLD FEMALE PATIENT WAS URGENTLY TREATED FOR PENETRATING AORTIC ULCER (CONTAINED RUPTURE) WITH PLACEMENT OF A ZTA-P-34-161, STARTING AT ZONE 1. THE STUDY PROCEDURE INCLUDED LEFT SUBCLAVIAN TO LEFT COMMON CAROTID BYPASS, LEFT SUBCLAVIAN EMBOLIZATION, AND CHIMNEY TECHNIQUE. PROCEDURE IMAGING REVEALED PATENT STUDY DEVICE, A TYPE IA ENDOLEAK, AND NO DEVICE ISSUES. DISCHARGE MEDICATIONS ARE UNKNOWN. ON THE SAME DATE, THE PATIENT EXPERIENCED PNEUMONIA WHICH WAS TREATED WITH ANTIBIOTICS AND NOT RELATED TO THE STUDY DEVICE BUT RELATED TO THE PROCEDURE. ADVERSE EVENTS HAVE ALSO BEEN ENTERED FOR THIS SAME DATE FOR TYPE IA ENDOLEAK AND TYPE II ENDOLEAK. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TYPE II WAS SUSPECTED FIRST, THOUGHT TO BE FROM THE LSA, WAS TREATED WITH COIL EMBOLIZATION ON (B)(6) 2019, AND WAS NOT RELATED TO THE STUDY DEVICE, RELATED TO THE PROCEDURE. THE SECONDARY INTERVENTION WAS NOT SUCCESSFUL, WITH POST-INTERVENTION BRACHIAL ARTERY THROMBOSIS AND PERSISTENT ENDOLEAK. THE TYPE IA ENDOLEAK WAS TREATED WITH SUCCESSFUL OPEN ARCH RECONSTRUCTION ON (B)(6) 2019 AND WAS NOT RELATED TO THE STUDY DEVICE BUT RELATED TO THE PROCEDURE. ON (B)(6) 2019, THE PATIENT EXPERIENCED ARTERIAL THROMBOSIS PROXIMAL TO THE STUDY STENT WHICH WAS TREATED WITH THROMBECTOMY/THROMBOLYSIS, WAS NOT RELATED TO THE STUDY DEVICE, RELATED TO THE STUDY PROCEDURE IN THAT IT WAS AN ADVERSE EVENT OF THE SECONDARY INTERVENTION REQUIRED DUE TO ENDOLEAK FROM STUDY PROCEDURE. ON 13FEB2019, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) REVEALED PATENT STUDY DEVICE, THROMBUS IN THE STUDY DEVICE, NO DEVICE ISSUES, AND TYPE IA ENDOLEAK (THIS COMPLAINT) (SECONDARY INTERVENTION ON (B)(6) 2019 AS NOTED ABOVE). THE PATIENT WAS TAKING ANTICOAGULANTS AND ASPIRIN. ON (B)(6) 2019, THE PATIENT EXPERIENCED ARTERIAL THROMBOSIS DISTAL TO THE STUDY STENT WHICH WAS TREATED WITH ¿ENDARTERECTOMY AND PATCHPLASTY OF COMMON FEMORAL ARTERY, SUPERFICIAL FEMORAL ARTERY, EXTERNAL ILIAC ARTERY LEFT,¿ WAS NOT RELATED TO THE STUDY DEVICE, AND RELATIONSHIP TO PROCEDURE WAS UNABLE TO BE DETERMINED. ON (B)(6) 2019, THE PATIENT EXPERIENCED RESPIRATORY INSUFFICIENCY, TREATED WITH TRACHEOSTOMY. THE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT RELATED TO THE PROCEDURE IN THAT THE PATIENT HAD NOT BEEN ABLE TO BE EXTUBATED. ON (B)(6) 2019, THE PATIENT EXPERIENCED CHOLECYSTITIS, WHICH WAS TREATED WITH OPEN CHOLECYSTECTOMY, AND WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. ON UNKNOWN DATES PRESUMABLY AFTER (B)(6) 2019, THE PATIENT EXPERIENCED RENAL FAILURE AND STROKE. THE RENAL FAILURE WAS TREATED WITH DIALYSIS AND NOT RELATED TO THE STUDY DEVICE, UNABLE TO DETERMINE RELATIONSHIP TO PROCEDURE. THE STROKE IS DESCRIBED AS ISCHEMIC WITH SEVERITY NOTED AS ¿EPILEPTIC SEIZURE,¿ PRESUMABLY TO DESCRIBE THE PATIENT¿S SYMPTOMS. IT WAS TREATED WITH MEDICATION AND NOTED AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. PATIENT OUTCOME: THE TYPE IA ENDOLEAK WAS TREATED WITH SUCCESSFUL OPEN ARCH RECONSTRUCTION ON (B)(6) 2019. THE SECONDARY INTERVENTION FOR THE TYPE IA ENDOLEAK WAS NOTED AS SUCCESSFUL. ON (B)(6) 2019, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN, WITH SITE COMMENT, ¿PATIENT DIED IN OUR HOSPITAL. BESIDE DATE OF DEATH, NO FURTHER INFORMATION ON CAUSE OF DEATH IS AVAILABLE.¿ BASED ON THE ABOVE AND THE PATIENT´S OTHER CO-MORBIDITIES AND LENGTHY HOSPITALIZATION IT IS ASSESSED THAT THE DEATH WAS UNLIKELY RELATED TO THE TYPE IA ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2663846 | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G34696 | E3793147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Required Intervention |