ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT
Report
- Report Number
- 3002808486-2020-00394
- Event Type
- Malfunction
- Date Received
- April 6, 2020
- Date of Event
- January 24, 2020
- Report Date
- July 21, 2021
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER REF# (B)(4). H6) E2402 - APPROPRIATE TERM / CODE NOT AVAILABLE FOR ENDOLEAK. SUMMARY OF INVESTIGATIONAL FINDINGS: A 67-YEAR-OLD FEMALE PATIENT WAS ENROLLED IN A CLINICAL STUDY AND HAD A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) PROCEDURE WITH AN ZDEG-PT-36-159-PF-CI DEVICE ON 07JAN2015 4½ YEARS POST-OP THE PATIENT HAD A THORACOABDOMINAL DISSECTION THAT WAS TREATED WITH AN AORTOBIFEMORAL BYPASS GRAFT ON 09APR2019 AND A FEVAR (FENESTRATED ENDOVASCULAR AORTIC REPAIR) AND BILATERAL FEMORAL CONDUIT GRAFT ON 02JUL2019. 24JAN2020 A CT SCAN SHOWED THAT THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FLOW FROM A TYPE 3 ENDOLEAK IN THE BODY OF THE DEVICE. FURTHERMORE, RIGHT AND LEFT RENAL INFARCTS WERE NOTED. NO SECONDARY INTERVENTION WAS PLANNED. REPEAT IMAGING IS PLANNED 6MONTHS POST VISIT. PREOPERATIVE, INTRAOPERATIVE AND ONE, SIX, 12, 24, 36, 48, AND 60-MONTH POST-OP CTAS WERE RECEIVED AND EVALUATED BY AN IMAGING EXPERT. PER IMAGING EXPERT REVIEW, A TYPE III ENDOLEAK INVOLVING THE ZDEG-PT-36-159-PF-CI DEVICE IS NOT CONFIRMED, HOWEVER TWO ENDOLEAKS, LIKELY TYPE IIIA, INVOLVING A T-BRANCH ARE CONFIRMED. BILATERAL LOWER POLE RENAL INFARCTS WERE PRESENT AT THE PATIENT'S ORIGINAL PRESENTATION WITH DISSECTION AND NO NEW INFARCTS AFTER T-BRANCH IMPLANTATION WERE SEEN. INSTRUCTIONS FOR USE STATES: CONSULT THE SELF-EXPANDING COVERED STENT MANUFACTURER¿S INSTRUCTIONS FOR SELECTING THE APPROPRIATE COVERED STENT. A MINIMUM 1-2 MM INTERFERENCE FIT AND A MINIMUM 15 MM OVERLAP BETWEEN THE SELF-EXPANDING COVERED VASCULAR BRIDGING STENTS AND THE SIDE BRANCHES OF THE ZENITH T-BRANCH IS SUGGESTED TO REDUCE THE RISK OF COMPONENT SEPARATION. THE LENGTH OF THE SELF-EXPANDING COVERED VASCULAR BRIDGING STENT TO BE USED IS DEPENDENT ON THE PATIENT¿S ANATOMY. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. IT IS NOTED THAT THE DEVICE HAS BEEN USED IN A DISSECTION PATIENT WHICH IS OFF LABEL USE. BASED ON THE REPORTED INFORMATION NO EXACT CAUSE COULD BE ESTABLISHED AFTER INVESTIGATION THE EVENT FOR THIS PR#296114 IS NO LONGER REPORTABLE, DUE TO A LOW SEVERITY AND HARM DOES NOT REQUIRE AN INTERVENTION. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
MANUFACTURER REF# (B)(4). PMA/510(K) P180001. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO STUDY: TYPE 3 ENTRY-FLOW 5 YEARS POST-PROCEDURE. ON (B)(6) 2015, THE PATIENT RECEIVED ONE COVERED STENT-GRAFT ZDEG-PT-36-159-PF-CI, LOT # E2879312 AND A DISSECTION STENT, ZDES-36-120-CI, LOT #E2981930. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICES. THE COMPLETION ANGIOGRAM SHOWED THAT THE DEVICES WERE PATENT WITH NO KINKS. THE FALSE LUMEN WAS COMPLETELY THROMBOSED IN BOTH THE THORACIC AND ABDOMINAL AREAS. ANALYSIS EVALUATION OF THE COMPLETION ANGIOGRAM SHOWED THAT THE FALSE LUMEN WAS PARTIALLY THROMBOSED IN BOTH THE THORACIC AND ABDOMINAL AREAS WITH COLLATERAL FLOW FROM THE PARASPINALS AND THE LUMBAR ARTERIES. THE POST-PROCEDURE FOLLOW-UP CT WAS NOT COMPLETED. ON (B)(6) 2015 (35 DAYS PP), THE ONE-MONTH FOLLOW-UP CT WAS COMPLETED. THE DEVICES WERE PATENT WITH NO EVIDENCE OF STENT FRACTURES OR KINKS. THE THORACIC FALSE LUMEN WAS SUPPLIED BY INTERCOSTAL COLLATERAL FLOW. A DISTAL TYPE I ENDOLEAK WAS PROVIDING FALSE LUMEN FLOW TO THE ABDOMINAL AREA ((B)(4)). THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH COLLATERAL FLOW FROM PARASPINAL ARTERIES. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FLOW FROM SECONDARY TEARS AT THE SMA, RIGHT RENAL, AND THE INFRARENAL AREA. THERE WAS ALSO COLLATERAL FLOW FROM LUMBAR ARTERIES. RIGHT RENAL ISCHEMIA WAS NOTED. ON (B)(6) 2015 (259 DAYS PP), THE SIX-MONTH FOLLOW-UP CT WAS COMPLETED. THE DEVICES WERE PATENT WITH NO EVIDENCE OF STENT FRACTURES, KINKS, OR MIGRATION. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AND SUPPLIED BY INTERCOSTAL COLLATERAL FLOW. THE ABDOMINAL FALSE LUMEN WAS PATENT WITH FLOW FROM A DISTAL TYPE I ENDOLEAK. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH COLLATERAL FLOW FROM INTERCOSTAL AND PARASPINAL ARTERIES. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FLOW FROM SECONDARY TEARS AT THE SMA, RIGHT RENAL, AND THE INFRARENAL AREA. THERE WAS ALSO COLLATERAL FLOW FROM LUMBAR ARTERIES. RIGHT RENAL ISCHEMIA WAS NOTED. ON (B)(6) 2016 (392 DAYS PP), THE 12-MONTH FOLLOW-UP CT WAS COMPLETED. THE DEVICES WERE PATENT WITH NO EVIDENCE OF STENT FRACTURES, KINKS, OR MIGRATION. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AND SUPPLIED BY INTERCOSTAL COLLATERAL FLOW. THE ABDOMINAL FALSE LUMEN WAS PATENT WITH FLOW FROM A DISTAL TYPE I ENDOLEAK. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH COLLATERAL FLOW FROM PARASPINAL ARTERIES. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FLOW FROM SECONDARY TEARS AT THE RIGHT RENAL AND THE INFRARENAL AREA. THERE WAS ALSO COLLATERAL FLOW FROM LUMBAR ARTERIES. NO RENAL ISCHEMIA OR INFARCTS WERE NOTED. ON (B)(6) 2017 (735 DAYS PP), THE 2-YEAR FOLLOW-UP CT WAS COMPLETED. THE DEVICES WERE PATENT WITH NO EVIDENCE OF STENT FRACTURES, KINKS, OR MIGRATION. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AND SUPPLIED BY INTERCOSTAL COLLATERAL FLOW. THE ABDOMINAL FALSE LUMEN WAS PATENT WITH FLOW FROM A DISTAL TYPE I ENDOLEAK. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH COLLATERAL FLOW FROM PARASPINAL ARTERIES. THE ABDOMINAL FALSE LUMEN WAS PATENT WITH FLOW FROM A SECONDARY TEAR AT THE RIGHT RENAL AND THE INFRARENAL AREA. THERE WAS ALSO COLLATERAL FLOW FROM LUMBAR ARTERIES. NO RENAL ISCHEMIA OR INFARCTS WERE NOTED. ON (B)(6) 2018 (1101 DAYS PP), THE 3-YEAR FOLLOW-UP CT WAS COMPLETED. THE DEVICES WERE PATENT WITH NO EVIDENCE OF STENT FRACTURES, KINKS, OR MIGRATION. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AND SUPPLIED BY INTERCOSTAL COLLATERAL FLOW. THE ABDOMINAL FALSE LUMEN WAS PATENT WITH FLOW FROM A SECONDARY TEAR IN THE RIGHT RENAL ARTERY AND COLLATERAL FLOW FROM THE LUMBAR ARTERIES. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH COLLATERAL FLOW FROM PARASPINAL ARTERIES. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FLOW FROM SECONDARY TEARS AT THE RIGHT RENAL AND THE INFRARENAL AREA. THERE WAS ALSO COLLATERAL FLOW FROM LUMBAR ARTERIES. RIGHT RENAL ISCHEMIA WAS NOTED. ON (B)(6) 2018 (1290 DAYS PP), THE PATIENT UNDERWENT SURGICAL REPLACEMENT OF THE ASCENDING AORTA AND THE AORTIC ARCH DUE TO A NEW TYPE A DISSECTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. ON (B)(6) 2019 (1483 DAYS PP), THE 4-YEAR FOLLOW-UP CT WAS COMPLETED. THE DEVICES WERE PATENT WITH NO EVIDENCE OF STENT FRACTURES, KINKS, OR MIGRATION. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AND SUPPLIED BY A SECONDARY TEAR IN THE INFRARENAL AORTA AND FROM INFRARENAL COLLATERAL FLOW. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FLOW FROM A SECONDARY TEAR IN THE INFRARENAL AREA AND COLLATERAL FLOW FROM THE LUMBAR ARTERIES. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH COLLATERAL FLOW FROM PARASPINAL ARTERIES. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FLOW FROM SECONDARY TEARS AT THE RIGHT RENAL AND THE INFRARENAL AREA. THERE WAS ALSO COLLATERAL FLOW FROM LUMBAR ARTERIES. RIGHT RENAL ISCHEMIA WAS NOTED. ON (B)(6) 2019 (1553 DAYS PP), THE PATIENT UNDERWENT PLACEMENT OF AN AORTOBIFEMORAL BYPASS GRAFT DUE TO A THORACOABDOMINAL ANEURYSM WITH DISSECTION. AN ADDITIONAL FEVAR PROCEDURE WAS PLANNED FOR THE NEAR FUTURE. ON (B)(6) 2019 (1637 DAYS PP), THE PATIENT UNDERWENT FOUR VESSEL FEVAR AND BILATERAL FEMORAL CONDUIT GRAFTS FOR TAA WITHOUT RUPTURE. ON (B)(6) 2020 (1843 DAYS PP), THE 5-YEAR FOLLOW-UP CT WAS COMPLETED. THE DEVICES WERE PATENT WITH NO EVIDENCE OF STENT FRACTURES, KINKS, OR MIGRATION. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FLOW FROM A TYPE 3 ENDOLEAK IN THE BODY OF THE DEVICE. THE SITE WAS QUERIED AS TO WHETHER AN SI IS PLANNED. THE QUERY RESPONSE WAS: ¿THERE IS NO SECONDARY INTERVENTION PLANNED AT THIS TIME. REPEAT IMAGING IS PLANNED 6 MONTHS POST THIS VISIT.¿ THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH COLLATERAL FLOW FROM LUMBAR ARTERIES. RIGHT AND LEFT RENAL INFARCTS WERE NOTED. PATIENT OUTCOME: NO TREATMENT PROVIDED. REPEAT IMAGING IN 6 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392025 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E2879312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |