ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2024-00190
- Event Type
- Injury
- Date Received
- September 25, 2024
- Report Date
- March 25, 2025
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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: DURING A LITERATURE REVIEW COOK BECAME AWARE OF THE ARTICLE ¿MANAGING FALSE LUMEN PATENCY IN CHRONIC THORACIC AORTIC DISSECTING ANEURYSMS WITH COIL EMBOLIZATION'. THE ARTICLE IS A CASE-RAPPORT DESCRIBING A 59-YEAR-OLD MALE WITH ACUTE COMPLICATED TYPE B THORACIC AORTIC DISSECTION. THE DISSECTION FLAP ORIGINATED DISTAL TO THE LEFT SUBCLAVIAN ARTERY, CAUSING SIGNIFICANT TRUE LUMEN COMPROMISE AND RESULTING IN SUPERIOR MESENTERIC ARTERY (SMA) AND RIGHT RENAL ARTERY OCCLUSION. THE DISSECTION EXTENDED DOWN TO THE PROXIMAL RIGHT COMMON ILIAC ARTERY. A ZDEG-34-154 WAS PLACED JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY AND TWO BARE STENTS WERE PLACED IN THE SMA. A RIGHT HEMICOLECTOMY WAS PERFORMED FOR BOWEL ISCHEMIA. THREE MONTHS POST-OPERATIVELY THE PATIENT PRESENTED WITH CHEST AND ABDOMINAL DISCOMFORT, A SCAN REVEALED EVIDENCE OF A PATENT FALSE LUMEN DISTAL TO THE STENT GRAFT WITH AN INCREASE IN AORTIC DIAMETER BY 1 CM SINCE THE INDEX SCAN. TO ADDRESS THIS, A TAPERED ZENITH DISSECTION ENDOVASCULAR GRAFT 34 × 159-MM AORTIC STENT GRAFT WAS PLACED DISTALLY, OVERLAPPING THE PREVIOUSLY PLACED GRAFT. DESPITE THE EXTENSION, THE PATIENT PRESENTED 10 MONTHS LATER WITH BACK PAIN. CT ANGIOGRAM SHOWED ENLARGEMENT OF THE TYPE IB ENDOLEAK, WHICH WAS CAUSING RETROGRADE FILLING OF THE FALSE LUMEN AND ENLARGEMENT OF THE THORACIC AORTA. AN ADDITIONAL ZENITH ALPHA THORACIC STENT GRAFT MEASURING 34 × 161 MM WAS PLACED DISTALLY, AND COIL EMBOLIZATION OF THE FALSE LUMEN WAS PERFORMED USING 6 PENUMBRA 60-CM PACKING COILS. ADEQUATE WALL APPOSITION OF THE DISTAL STENT WAS NOTED, WITH COMPLETE EXCLUSION OF THE FALSE LUMEN. BASED ON THE PROVIDED INFORMATION THIS AND THE RELATED COMPLAINT WILL COVER A TYPE 1B ENDOLEAK FOR EACH OF THE USED ZDEG DEVICES. PER THE INSTRUCTIONS FOR USE SENT WITH THIS TYPE OF DEVICE BOTH ENDOLEAK AND PERSISTENT FLOW INTO FALSE LUMEN ARE KNOWN ADVERSE EVENTS. BASED ON THE PROVIDED INFORMATION SEVERAL FACTORS COULD HAVE CONTRIBUTED TO THE DEVELOPMENT OF TYPE 1B FLOW INTO FALSE LUMEN, WHY IT HAS NOT BEEN POSSIBLE TO ESTABLISH AN EXACT CAUSE FOR THESE EVENTS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
DESCRIPTION OF EVENT ACCORDING TO LITERATURE ARTICLE: THE DISSECTION FLAP ORIGINATED DISTAL TO THE LEFT SUBCLAVIAN ARTERY, CAUSING SIGNIFICANT TRUE LUMEN COMPROMISE AND RESULTING IN SUPERIOR MESENTERIC ARTERY (SMA) AND RIGHT RENAL ARTERY OCCLUSION (FIG. 2). THE DISSECTION EXTENDED DOWN TO THE PROXIMAL RIGHT COMMON ILIAC ARTERY. AN EMERGENCY AORTOGRAM WAS PERFORMED TO PLACE A ZENITH DISSECTION ENDOVASCULAR GRAFT, A 34 × 154-MM THORACIC ENDOGRAFT, JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY. OVERLAPPING BARE METAL BALLOON-EXPANDABLE STENTS (6 × 59-MM STENT FOLLOWED BY A 7 × 59-MM STENT) WERE PLACED IN THE SMA TO REGAIN LUMINAL PATENCY. A RIGHT HEMICOLECTOMY WAS PERFORMED FOR BOWEL ISCHEMIA. THE PATIENT RECOVERED WELL AND WAS DISCHARGED TO THE REHABILITATION UNIT. THREE MONTHS POSTOPERATIVELY, THE PATIENT PRESENTED WITH CHEST AND ABDOMINAL DISCOMFORT. COMPUTED TOMOGRAPHY (CT) ANGIOGRAM DEMONSTRATED EVIDENCE OF A PATENT FALSE LUMEN DISTAL TO THE STENT GRAFT WITH AN INCREASE IN AORTIC DIAMETER BY 1 CM SINCE THE INDEX SCAN. TO ADDRESS THIS, A TAPERED ZENITH DISSECTION ENDOVASCULAR GRAFT 34 × 159-MM AORTIC STENT GRAFT WAS PLACED DISTALLY, OVERLAPPING THE PREVIOUSLY PLACED GRAFT. EFFORT WAS MADE TO AVOID COVERING THE DISTAL LUMBAR BRANCHES AND REDUCE THE RISK OF SPINAL ISCHEMIA, WITH SPINAL DRAINS USED INTRAOPERATIVELY. THE RIGHT HYPOGASTRIC WAS PATENT BUT HAD DIMINISHED FLOW, AND THE LEFT HYPOGASTRIC WAS OCCLUDED. PATIENT OUTCOME: INCREASE IN AORTIC DIAMETER BY 1 CM. TO ADDRESS THIS, A TAPERED ZENITH DISSECTION ENDOVASCULAR GRAFT 34 × 159MM AORTIC STENT GRAFT WAS PLACED DISTALLY, OVERLAPPING THE PREVIOUSLY PLACED 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 |
|---|---|---|---|---|---|---|---|
| 2234235 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Required Intervention |