ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2025-00163
- Event Type
- Injury
- Date Received
- July 29, 2025
- Date of Event
- July 10, 2025
- Report Date
- March 11, 2026
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 00827002449466
- 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: A 82-YEAR-OLD MALE PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR A THORACIC AORTIC ANEURYSM (TAA) AT THE AORTA ARCH AFTER TOTAL ARCH REPLACEMENT (TAR) + FROZEN ELEPHANT TRUNCK (FET) WAS CONDUCTED. THE TAA WAS LOCATED AT THE DISTAL PART OF THE FET. TEVAR WAS PERFORMED AS EXTENDING THE FET. THIS WAS A DIFFICULT CASE TO ACCESS SINCE THE STRONG TORTUOUS ANATOMY DUE TO ABDOMINAL Y-GRAFT REPLACEMENT PERFORMED PREVIOUSLY. ALSO, THE FET PRESENTED A STEEP ARCH. THE USER USED PULL-THROUGH TECHNIQUE FROM THE RIGHT BRACHIAL ARTERY TO THE LEFT FEMORAL ARTERY, AND ADVANCED THE DELIVERY SYSTEM OF ZTA-P-30-155-W1 OVER A 0.035¿ WIRE GUIDE (MEDICOS HIRATA¿S EGOIST ULTIMATE DOUBLE CURVED). HOWEVER, THE DELIVERY SYSTEM WOULD NOT ADVANCE AFTER IT PASSED THE APEX OF THE ARCH OF THE FET. THEN, WHEN THE USER TRIED TO ADVANCE IT FURTHER, THE DELIVERY SYSTEM BENT/BOWED UPWARDS AND THE TAA RUPTURED AND DROP IN HEART RATE WAS CONFIRMED. AS AN EMERGENCY MEASURE, THE USER DEPLOYED THE STENT GRAFT IN THE POSITION WHERE THE DELIVERY SYSTEM WAS STOPPED. THEN THE PHYSICIAN RELEASED THE TRIGGER WIRES AND CONFIRMED THE PROXIMAL BARE STENTS WERE RELEASED. THEN THE PHYSICIAN TRIED TO REMOVE THE DILATOR TIP CAREFULLY SINCE THE FET WAS STEEP, BUT THE DILATOR TIP GOT CAUGHT IN THE DEPLOYED STENT GRAFT AND THE STENT GRAFT WAS MIGRATED DISTALLY WHERE IT DOESN¿T OVERLAP WITH THE FET. THE PATIENT WAS CONNECTED TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WHILE RECEIVING CARDIAC MASSAGE. THE USER TRIED TO DO PULL-THROUGH TECHNIQUE AT THE RUPTURED SITE BUT FAILED. THE USER ENDED THE PROCEDURE. THE PATIENT DECEASED. THE USER COMMENTED THAT THE RUPTURE WAS NOT CAUSED BY A FAULTY OR DEFECTIVE ZENITH DEVICE. IN ADDITION THE USER AND THE SALES REPRESENTATIVE COMMENTED: DUE TO STRONG STEEP AND THE ARCH OF THE FET, WHEN TRYING TO MOVE THE DELIVERY SYSTEM FORWARD FURTHER, THE TORQUE WAS DIRECTED UPWARDS. 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. WHEN THE COMPLAINT WAS RECEIVED IT WAS NOTED THAT NO FURTHER INFORMATION COULD BE PROVIDED, WHY PROCEDURAL IMAGES WHERE NOT PROVIDED. 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 INSTRUCTIONS FOR USE AND/OR LABEL. THE PATIENT ANATOMY WAS DESCRIBED WITH STRONG TORTUOSITY AND THE FET PRESENTED A STEEP ARCH. ACCORDING TO THE INSTRUCTION FOR USE ¿NO LOCALIZED ANGULATION SHOULD BE LARGER THAN 45 DEGREES.¿ IT IS ASSESSED THAT THE REPORTED STRONG TORTUOSITY AND THE STEEP ARCH REFER TO ANGULATION LARGER THAN 45 DEGREES. THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE PRODUCT LABELLING AND/OR INSTRUCTIONS, THEREFORE IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION. AS THE COMPLAINT INVOLVES PATIENT DEATH A CLINICAL ASSESSMENT OF THE PROVIDED INFORMATION IS PERFORMED BY MEDICAL ADVISOR. PER THE CLINICAL ASSESSMENT ¿THIS ELDERLY PATIENT HAD EXTENSIVE AORTIC DEGENERATION, AS EVIDENCED BY THE NUMBER AND COMPLEXITY OF PREVIOUS AORTIC PROCEDURES. THIS, ALSO LED TO SEVERE TECHNICAL CHALLENGES IN TERMS OF ACCESS WITH THE PHYSICIAN ATTEMPTING AN UNUSUAL PULL THROUGH TECHNIQUE FROM THE RIGHT BRACHIAL TO THE LEFT FEMORAL ARTERY. MANIPULATION OF THE STUCK DELIVERY SYSTEM CAUSED THE RUPTURE OF THE TAA, WHICH LED TO THE PATIENT¿S DEATH.¿ A DEFINITIVE CAUSE WAS IDENTIFIED. THE PATIENT HAD EXTENSIVE AORTIC DEGENERATION, AS EVIDENCED BY THE NUMBER AND COMPLEXITY OF PREVIOUS AORTIC PROCEDURES, WHICH RESULTED IN BOTH STRONG TORTUOSITY RELATED TO THE PREVIOUSLY PLACED ABDOMINAL Y-GRAFT AND A STEEP ARCH RELATED TO THE FROZEN ELEPHANT TRUNK. THE CHALLENGING PATIENT ANATOMY RESULTED IN THAT THE FORCES APPLIED TO ADVANCE THE INTRODUCTION SYSTEM PAST THE STEEP ARCH WERE DIRECTED UPWARDS, CAUSING THE RUPTURE. IT IS ASSESSED THAT THE CHALLENGING PATIENT ANATOMY CONTRIBUTED TO THE EVENT. 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). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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 INITIAL REPORTER: THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WAS PERFORMED FOR THE THORACIC AORTIC ANEURYSM (TAA) AT THE AORTA ARCH AFTER TOTAL ARCH REPLACEMENT (TAR) + FROZEN ELEPHANT TRUNK (FET) WAS CONDUCTED. THE TAA WAS LOCATED AT THE DISTAL PART OF THE FET. TEVAR WAS PERFORMED AS EXTENDING THE FET. THIS WAS A DIFFICULT CASE TO ACCESS SINCE THE STRONG TORTUOUS ANATOMY DUE TO ABDOMINAL Y-GRAFT REPLACEMENT PERFORMED PREVIOUSLY. ALSO, THE FET PRESENTED A STEEP ARCH. THE USER USED PULL-THROUGH TECHNIQUE FROM THE RIGHT BRACHIAL ARTERY TO THE LEFT FEMORAL ARTERY, AND ADVANCED THE DELIVERY SYSTEM OF ZTA-P-30-155-W1 OVER A 0.035¿ WIRE GUIDE (MEDICOS HIRATA¿S EGOIST ULTIMATE DOUBLE CURVED). HOWEVER, THE DELIVERY SYSTEM WOULD NOT ADVANCE AFTER IT PASSED THE APEX OF THE ARCH OF THE FET. THEN, WHEN HE TRIED TO ADVANCE IT FURTHER, THE DELIVERY SYSTEM BENT/BOWED UPWARDS AND THE TAA RUPTURED AND DROP IN HEART RATE WAS CONFIRMED. AS AN EMERGENCY MEASURE, THE USER DEPLOYED THE STENT GRAFT IN THE POSITION WHERE THE DELIVERY SYSTEM WAS STOPPED. THEN HE RELEASED THE TRIGGER WIRES AND CONFIRMED THE PROXIMAL BARE STENTS WERE RELEASED. THEN HE TRIED TO REMOVE THE DILATOR TIP CAREFULLY SINCE THE FET WAS STEEP, BUT THE DILATOR TIP GOT CAUGHT IN THE DEPLOYED STENT GRAFT AND THE STENT GRAFT WAS MIGRATED DISTALLY WHERE IT DOESN¿T OVERLAP WITH THE FET. THE PATIENT WAS CONNECTED TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WHILE RECEIVING CARDIAC MASSAGE. THE USER TRIED TO DO PULL-THROUGH TECHNIQUE AT THE RUPTURED SITE, BUT FAILED. THE USER ENDED THE PROCEDURE. PATIENT OUTCOME: DROP IN HEART RATE. CONNECTED TO ECMO. THE PATIENT DECEASED. THE USER COMMENTED THAT THE RUPTURE WAS NOT CAUSED BY A FAULTY OR DEFECTIVE ZENITH DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463853 | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G44946 | E4596665 | 00827002449466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Life Threatening |