MAUDE Adverse Event Report: COOK, INC. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZSLE-16-74-ZT

Device Problem Kinked (1339)

Patient Problems Stenosis (2263); Surgical procedure, additional (2564)

Event Date 02/06/2015

Event Type  Injury  

Event Description

From a study being conducted: the pt's abdominal aneurism measured approximately 50 mm in diameter with a parallel neck and no plaque/thrombus.There was moderate tortuosity of the right iliac artery and mild tortuosity of the left iliac artery.There was no occlusive disease and no calcification of either iliac artery.Core lab analysis of the pre-procedure imaging noted an abdominal aneurysm approximately 51.2 mm in diameter.The aaa had a parallel neck with partial plaque/thrombus.Core lab noted moderate tortuosity, mild occlusive disease and mild calcification of the bilateral iliac arteries.The initial physical examination revealed an irregular pulse and atrial fibrillation.The pt was noted to be asa class 3.The pt was taking the following medications at the time of the enrollment: an angiotension ii receptor blocker, antiplatelet agent, calcium channel blocker, anticoagulant, beta blocker, and lipid lowering agent.The results of pre-procedure blood work, done on (b)(6) 2014 (13 days pre-procedure), revealed a creatinine of 0.9 mg/dl.Under general anesthesia, the patient underwent placement of a three-piece aaa endovascular graft.A 26 mm x 98 mm main body component a 16 mm x 7 4 mm ipsilateral (right) iliac leg graft, and a 16 mm x 74 mm contralateral (left) iliac leg graft were deployed.The proximal edge of the graft material was deployed distal to the renal arteries.A molding balloon was used during the procedure without difficulty or complications.No ancillary components were used and no additional procedures were performed.The completion angiogram demonstrated that the endovascular graft was patent with no evidence of a kink or an endoleak.Core lab analysis of the completion angiogram noted a patent graft with no evidence of a kink or endoleaks.The patient's estimated blood loss was 100 cc and no blood products were given intra-operatively.No patient-related adverse events were observed during the procedure.On (b)(6) 2014 (one day post-procedure), the post-procedure blood work and pre-discharge evaluation was performed.The blood work revealed a creatinine of 1.10 mg/dl the physical exam was unremarkable and both right and left entry sites were in satisfactory condition.On the same day, the patient was discharged taking anticoagulant and antiplatelet medication.On (b)(6) 2014 (36 days post-procedure), the one-month follow up x-ray was performed.The x-ray demonstrated an intact device with no noticeable barb separation, stent fractures, component separation, migration, or device stenosis.There was evidence of a kink.Investigational site lab noted the kink was "mild-probable infolding of fabric in between stents causing mild stenosis in right iliac».Core lab analysis of the x-ray demonstrated an intact device with no noticeable barb separation, stent fractures, component separation, device compression or kink.On (b)(6) 2014 (43 days post-procedure), the one-month follow up physical exam, blood work and ct scan were performed.The physical exam was unremarkable.The patient's creatinine was 1.2 mg/dl.Since the last visit, the patient had not developed any new diagnoses, had any significant medical problems, or been hospitalized for any reason.The ct scan revealed a patent graft with no evidence of endoleak.A kink in the right iliac leg was noted.The maximum aortic diameter measured 52 mm.Core lab analysis of the ct scan noted a patent graft with no evidence of endoleak.Maximum aortic diameter measured 57.5 mm.It was noted "moderate stenosis of sma, mild stenosis of celiac, coil embolization of ima".On (b)(6) 2015 (102 days post-procedure), the patient underwent a secondary intervention to correct device stenosis of the right iliac limb.Angioplasty was performed and a stent was placed.On (b)(6) 2015, upon completion of the investigation, this event was determined to be reportable.

Manufacturer Narrative

(b)(4).Investigation evaluation: a review of the complaint history, instructions for use (ifu), and trends was conducted for the purpose of this investigation.No product or images were returned to assist with this investigation.Each zenith device is shipped with the ifu listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.In regards to occlusions, the ifu lists several warnings/precautions that, if followed, could prevent this failure mode from occurring or lessen the associated effects; anatomical criteria, anatomical conditions and importance of accurate placement.Specific to this case zenith ifu's state: "patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures." / ''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." it was concluded that the failure mode for this case was kinked.The risk remains at an acceptable level with inclusion of this event.No additional risk reduction is required at this time.Based on the information provided, a definitive cause for the kink cannot be determined or reported at this time.There is no evidence to suggest that the device design or functionality contributed to this event.We will continue to monitor for similar complaints and notify the appropriate internal personnel.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4853565
• MDR Text Key: 5869759
• Report Number: 1820334-2015-00343
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 5079283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 115