ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

Report

Report Number: 1820334-2021-01793
Event Type: Injury
Date Received: July 14, 2021
Date of Event: July 9, 2021
Report Date: January 3, 2022
Manufacturer: COOK INC
Product Code: MIH
PMA / PMN Number: P020018
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION ON 09JUL2021, COOK BECAME AWARE OF AN EVENT IN WHICH AN 82-YEAR-OLD MALE PATIENT PRESENTED WITH POSSIBLE STENOSIS IN THE LEFT COMMON ILIAC LEG GRAFT FOUND DURING A ROUTINE FOLLOW-UP. THE COMPLAINT DEVICE IS EITHER RPN: ZSLE-13-107-ZT (LOT: 3990720) OR RPN: ZSLE-20-56-ZT (LOT: 4240127). THE DEVICE WAS IMPLANTED ON (B)(6) 2014 ALONG WITH RPN: TFFB-26-96-ZT (LOT: 4632107). THE LIMB WAS DOCKED INTO THE IPSILATERAL PORTION OF THE MAIN BODY GRAFT. THE STENOSIS WAS CONTAINED INSIDE THE OVERLAP OF THE IPSILATERAL LIMB AND THE PROXIMAL EDGE OF THE ILIAC LEG GRAFT. THE SURGEON RE-INTERVENED BY DOING A BALLOON ANGIOPLASTY TO OPEN THE LEFT COMMON ILIAC LEG GRAFT SEGMENT. THE ISSUE SEEMED TO BE RESOLVED AND THE PHYSICIAN WAS HAPPY WITH THE OUTCOME. IT WAS ALSO NOTED THAT THE PATIENT HAS AN ALLERGY TO IODINE AND HAD POSSIBLE STENOSIS PRIOR TO THE PROCEDURE BEING DONE. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, INTRAOPERATIVE IMAGING WAS PROVIDED TO COOK AND SUBMITTED FOR EXPERT IMAGE REVIEW. THE REVIEWER NOTED THAT WITHOUT REVIEW OF POSTOP IMAGING, IT CANNOT BE DETERMINED IF THERE WAS STENOSIS PRESENT POST-IMPLANTATION. THE IMAGING PROVIDED CANNOT BE MEASURED DUE TO FORMATTING. IN ADDITION, CONTRAST ENHANCEMENT IS VISUALIZED ON BOTH SIDES. COOK CONCLUDES THE DEVICE WAS MANUFACTURED PER SPECIFICATION. ADDITIONALLY, 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 (DHF) SHOWED THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHRS FOR BOTH POTENTIAL COMPLAINT DEVICE LOTS (3990720 AND 4240127) AS WELL AS THEIR RELATED GRAFT AND GRAFT KIT SUBASSEMBLY LOTS REVEALED NO RECORDED NONCONFORMANCES. IT SHOULD BE NOTED THAT ZSLE- DEVICES ARE DISTRIBUTED VIA ONE-DEVICE LOTS, GIVING NO INDICATION OF NONCONFORMING PRODUCT IN HOUSE. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH EITHER POTENTIAL LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO INFORMATION SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. DEVICE LOT 3990720 WAS PACKAGED WITH IFU T_ZAAASZ_REV1; DEVICE LOT 4240127 WAS PACKAGED WITH IFU T_ZAAASZ_REV2. BOTH REVISIONS OF THE IFU CONTAIN THE FOLLOWING INSTRUCTIONS, WARNINGS, PRECAUTIONS, AND PROPER PLACEMENT INFORMATION FOR THE DEVICE RELATIVE TO THE REPORTED INCIDENT: ¿4 WARNINGS AND PRECASUTIONS 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ADEQUATE ILIAC OR FEMORAL ACCESS IS REQUIRED TO INTRODUCE THE DEVICE INTO THE VASCULATURE. ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL) AND MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND 12 FR (4.7 MM OD) OR 14 FR (5.3 MM OD) INTRODUCTION SYSTEMS. 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 OR THROMBOSIS. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. INABILITY TO MAINTAIN PATENCY OF AT LEAST ONE INTERNAL ILIAC ARTERY OR OCCLUSION OF AN INDISPENSABLE INFERIOR MESENTERIC ARTERY MAY INCREASE THE RISK OF PELVIC/BOWEL ISCHEMIA. 5 ADVERSE EVENTS 5.2 POTENTIAL ADVERSE EVENTS ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM CLAUDICATION (E.G., BUTTOCK, LOWER LIMB) ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT: COMPONENT MIGRATION: COMPONENT SEPARATION FROM ANOTHER GRAFT COMPONENT: SUTURE BREAK: OCCLUSION: INFECTION: STENT FRACTURE: GRAFT MATERIAL WEAR: DILATATION: EROSION: PUNCTURE: PERIGRAFT FLOW: AND CORROSION GRAFT OR NATIVE VESSEL OCCLUSION RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ARTERY OCCLUSION, CONTRAST TOXICITY, INSUFFICIENCY, FAILURE) 7 PATIENT SELECTION AND TREATMENT 7.1 INDIVIDUALIZATION OF TREATMENT ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIFICATION AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES OF THE DELIVERY PROFILE OF A 14 FRENCH TO 16 FRENCH VASCULAR INTRODUCER SHEATHS. 8 PATIENT COUNSELING INFORMATION PHYSICIANS MUST ADVISE ALL PATIENTS THAT IT IS IMPORTANT TO SEEK PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE SIGNS OF LIMB OCCLUSION, ANEURYSM ENLARGEMENT OR RUPTURE. SIGNS OF GRAFT LIMB OCCLUSION INCLUDE PAIN IN THE HIP(S) OR LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG. ANEURYSM RUPTURE MAY BE ASYMPTOMATIC, BUT USUALLY PRESENTS AS: PAIN; NUMBNESS; WEAKNESS IN THE LEGS; ANY BACK, CHEST, ABDOMINAL OR GROIN PAIN; DIZZINESS; FAINTING RAPID HEARTBEAT OR SUDDEN WEAKNESS. PHYSICIANS SHOULD REFER PATIENTS TO THE PATIENT GUIDE REGARDING RISKS OCCURRING DURING OR AFTER IMPLANTATION OF THE DEVICE. PROCEDURE-RELATED RISKS INCLUDE CARDIAC, PULMONARY, NEUROLOGIC, BOWEL AND BLEEDING COMPLICATIONS. DEVICE-RELATED RISKS INCLUDE OCCLUSION, ENDOLEAK, ANEURYSM ENLARGEMENT, FRACTURE, POTENTIAL FOR REINTERVENTION AND OPEN SURGICAL CONVERSION, RUPTURE, AND DEATH (SEE SECTION 5.1, OBSERVED ADVERSE EVENTS AND SECTION 5.2, POTENTIAL ADVERSE EVENTS). THE PHYSICIAN SHOULD COMPLETE THE PATIENT I.D. CARD AND GIVE IT TO THE PATIENT SO THAT HE/SHE CAN CARRY IT WITH HIM/HER AT ALL TIMES. THE PATIENT SHOULD REFER TO THE CARD ANYTIME HE/SHE VISITS ADDITIONAL HEALTH PRACTITIONERS, PARTICULARLY FOR ANY ADDITIONAL DIAGNOSTIC PROCEDURES (E.G., MRI). 12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP 12.1 GENERAL THE COMBINATION OF CONTRAST AND NON-CONTRAST CT IMAGING PROVIDES INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY, PROGRESSIVE DISEASE, FIXATION LENGTH AND OTHER MORPHOLOGICAL CHANGES. DUPLEX ULTRASOUND IMAGING MAY PROVIDE INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY, AND PROGRESSIVE DISEASE. IN THIS CIRCUMSTANCE, A NON-CONTRAST CT SHOULD BE PERFORMED TO USE IN CONJUNCTION WITH THE ULTRASOUND. ULTRASOUND MAY BE A LESS RELIABLE AND SENSITIVE DIAGNOSTIC METHOD COMPARED TO CT.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A POTENTIAL ROOT CAUSE FOR THIS EVENT WAS NOT TRACED TO THE DEVICE, BUT RATHER THE PATIENT'S CONDITION. IT WAS REPORTED THAT THE PATIENT POSSIBLE HAD STENOSIS PRIOR TO THE PROCEDURE, ALONG WITH HAVING AN ALLERGY TO IODINE, POTENTIALLY CONTRIBUTING TO THE FAILURE MODE. HOWEVER, WITH THE AVAILABLE INFORMATION, ADDITIONAL PATIENT PRE-EXISTING CONDITIONS, CO-MORBIDITIES, PATIENT ANATOMY/PHYSIOLOGY, AND/OR THE MEDICAL PROCEDURE WERE UNABLE TO BE RULED OUT AS CONTRIBUTING FACTORS. IT SHOULD BE NOTED THAT STENOSIS DEVELOPMENT 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 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.

Description of Event or Problem · 0

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Additional Manufacturer Narrative · 1

DEVICE IS EITHER: PRODUCT IDENTIFIER- G55234-ZSLE-13-107-ZT. RPN- ZSLE-13-107-ZT. PRODUCT LOT #- 3990720. OR: PRODUCT IDENTIFIER- G55241-ZSLE-20-56-ZT. RPN- ZSLE-20-56-ZT. PRODUCT LOT #- 4240127. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG STENOSED. DURING A ROUTINE FOLLOW-UP APPOINTMENT, THE PATIENT PRESENTED WITH POSSIBLE STENOSIS "INSIDE THE OVERLAP OF THE IPSILATERAL LIMB AND THE PROXIMAL EDGE OF THE ILIAC LEG GRAFT". AS A RESULT, BALLOON ANGIOPLASTY WAS SUCCESSFULLY PERFORMED TO OPEN THE POTENTIALLY STENOSED SEGMENT. IT WAS ALSO REPORTED THAT THE PATIENT WILL BE SEEN BY THE PHYSICIAN APPROXIMATELY ONE MONTH AFTER THE INTERVENTION TOOK PLACE. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. AN ADDITIONAL EVENT REGARDING THIS PATIENT IS ALSO REPORTED UNDER PATIENT IDENTIFIER: (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1062012	ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	COOK INC

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR	Male	Required Intervention	COOK TFFB-26-96-ZT, LOT 4632107\| COOK TFFB-26-96-ZT, LOT 4632107