ZENITH RENU AAA ANCILLARY GRAFT CONVERTER
Report
- Report Number
- 1820334-2019-03090
- Event Type
- Injury
- Date Received
- December 12, 2019
- Report Date
- July 1, 2020
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002553764
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. H6 ¿ METHOD CODE: (4114) DEVICE NOT RETURNED INVESTIGATION - EVALUATION. A REPRESENTATIVE FROM UNIVERSITY HOSPITAL NOTIFIED COOK OF AN INCIDENT INVOLVING A ZENITH RENU AAA ANCILLARY GRAFT CONVERTER (AX1-2-28-113-ZT) FROM LOT NUMBER 8080838. A 58-YEAR-OLD MALE PRESENTED TO THE EMERGENCY ROOM FOR A CT SCAN PROMPTED BY A SUSPECTED TOTAL DISTAL AORTA OCCLUSION. THE DM REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. THE STENT GRAFT WAS EXPLANTED ON (B)(6) 2019 WITH NO PLANS OF REPLACING IT. THE PATIENT WILL BE IN NEED OF A TOTAL AORTIC REBUILD AND REQUIRE AN AORTIC BI-FEMORAL PROCEDURE. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI) AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE SHOWED THAT THE AFFECTED PRODUCT IS SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED COMPLAINT DEVICE LOT (8080838) AND THE RELATED SUB-ASSEMBLY LOTS REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH DID NOT REVEAL ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. IT SHOULD BE NOTED THAT AX1 DEVICES ARE ONE-DEVICE LOTS. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. BASED UPON THE GIVEN INFORMATION, COOK HAS ALSO CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. EACH ZENITH RENU AAA ANCILLARY GRAFT CONVERTER DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU). THIS DOCUMENT INCLUDES THE FOLLOWING INSTRUCTIONS FOR USE, CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS REGARDING USE OF THIS DEVICE: " 4 WARNINGS AND PRECAUTIONS 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP THE (B)(4) IS NOT INTENDED FOR PRIMARY ENDOVASCULAR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS. IT IS INTENDED FOR USE IN PATIENTS IN WHOM AN ENDOVASCULAR GRAFT HAS ALREADY BEEN PLACED. ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING AN ENLARGING ANEURYSM, UNACCEPTABLE FIXATION LENGTH (BOTH THE VESSEL AND COMPONENT OVERLAPS) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK OR MIGRATION MAY LEAD TO ANEURYSM RUPTURE. PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G. ENDOLEAKS, ENLARGING ANEURYSM OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. IRREGULAR CALCIFICATION AND /OR PLAQUE MAY COMPROMISE THE ATTACHMENT AND SEALING AT THE FIXATION SITES. ADEQUATE ILIAC OR FEMORAL ACCESS IS REQUIRED TO INTRODUCE THE DEVICE INTO THE VASCULATURE. ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL), MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION), AND PRE-EXISTING GRAFT DIAMETER SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEM OF A 16 TO 22 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. INABILITY TO MAINTAIN PATENCY OF AT LEAST ONE INTERNAL ILIAC ARTERY OR OCCLUSION OF AN INDISPENSIBLE INFERIOR MESENTERIC ARTERY MAY INCREASE THE RISK OF PELVIC/BOWEL ISCHEMIA. 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING. LACK OF NON-CONTRAST CT IMAGING MAY RESULT IN FAILURE TO APPRECIATE ILIAC OR AORTIC CALCIFICATION, WHICH MAY PRECLUDE ACCESS OR RELIABLE DEVICE FIXATION AND SEAL. SECTION 4.4 DEVICE SELECTION: STRICT ADHERENCE TO THE ZENITH RENU AAA ANCILLARY GRAFT IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE (TABLES 10.5.1 THROUGH 10.5.2). APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING OR COMPRESSION. 4.5 IMPLANT PROCEDURE: UNLESS MEDICALLY INDICATED, DO NOT DEPLOY THE ZENITH RENU AAA ANCILLARY GRAFT IN A LOCATION THAT WILL OCCLUDE ARTERIES NECESSARY TO SUPPLY BLOOD FLOW TO ORGANS OR EXTREMITIES. DO NOT COVER SIGNIFICANT RENAL OR MESENTERIC ARTERIES (EXCEPTION IS THE INFERIOR MESENTERIC ARTERY) WITH THE ENDOPROSTHESIS. VESSEL OCCLUSION MAY OCCUR. 5 POTENTIAL ADVERSE EVENTS: ENDOPROSTHESIS: IMPROPER PLACEMENT; INCOMPLETE DEPLOYMENT; MIGRATION; COMPONENT SEPARATION; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; BARB SEPARATION AND CORROSION -- GRAFT OR NATIVE VESSEL OCCLUSION 7 PATIENT SELECTION AND TREATMENT -- USE OF THE ZENITH RENU AAA CONVERTER TYPICALLY REQUIRES OCCLUSION OF THE CONTRALATERAL ILIAC ARTERY IN CONJUNCTION WITH A STANDARD FEMORAL-TO-FEMORAL BYPASS PROCEDURE.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. HOWEVER, IT SHOULD BE NOTED THAT THROMBUS FORMATION IS A KNOWN INHERENT RISK OF USING THIS DEVICE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTION: B5. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
CLARIFICATION OF THE TYPE OF SECONDARY PROCEDURE THE PATIENT REQUIRED AFTER THE GRAFT WAS EXPLANTED WAS RECEIVED ON 11DEC2019. THE PATIENT REQUIRED AN AORTIC BI-FEM PROCEDURE AFTER THE GRAFT WAS EXPLANTED.
CONCOMITANT MEDICAL PRODUCTS: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, ZSLE-16-39-ZT (LOT # 8080838). (B)(6). (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT A ZENITH RENU AAA ANCILLARY GRAFT CONVERTER DEVICE HAD COMPLETELY OCCLUDED. THE ZENITH RENU AAA ANCILLARY GRAFT CONVERTER AND A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG HAD BEEN IMPLANTED IN A (B)(6) YEAR OLD MALE ON AN UNKNOWN DATE. THE PATIENT HAD COME INTO THE EMERGENCY ROOM FOR A CT SCAN DUE TO A SUSPECTED TOTAL AORTA OCCLUSION, THOUGH THE PATIENT WAS ASYMPTOMATIC. IT WAS CONFIRMED BASED ON THE SCAN THAT THE DEVICE HAD COMPLETELY OCCLUDED. THE DEVICE WAS EXPLANTED ON (B)(6) 2019 BUT NOT REPLACED. THE PATIENT WILL REQUIRE A TOTAL AORTIC REBUILD. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME, INITIAL IMPLANT INFORMATION, AND MEDICATIONS WERE REQUESTED BUT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1257067 | ZENITH RENU AAA ANCILLARY GRAFT CONVERTER | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 8080838 | 10827002553764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R |