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

Catalog Number	ZSLE-13-90-ZT
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a aaa procedure, after the main body was placed, the 13 mm x 90 mm iliac leg graft was placed, but it was much too short.Intraoperative, the physician measured the leg graft in the x-ray with a centimeter sizing catheter.He measured a 74mm long leg instead of a 90mm leg.The leg implanted was a 13 mm x 74 mm and not a 13 mm x 90 mm.The label in the packaging was incorrect.The physician implanted an additional leg extension to reach the proper length.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, specifications and trends have been conducted for the purpose of this investigation.The device was not returned to assist with the investigation.However, imaging was provided.It should be noted that prior to deployment, if ct scans are used to capture images of the graft loaded in the sheath, the length of the graft may appear to be shorter than post deployment (actual) length.This does not represent a defective product but rather how the graft is loaded into the sheath.Therefore, devices that are ct scanned, may give the appearance that the graft is shorter than the length captured by label copy.Once removed from the delivery system, the graft will deploy to the expected lengths.No other complaints were found as this product is one per lot.The device is shipped with the ifu, which lists warnings and precautions as well as instructions for proper placement and use of this device.The device was not returned to assist with the evaluation and the lot number was provided.A review of the complaint history, device history records concluded that there is no evidence to suggest that the product was not manufactured to specification.In addition, no additional product containing potential nonconformities has been found in house or in field.The results of this investigation show that the device delivered to the customer was the correct length; the customer felt that the length was too short due to its shortened un-deployed length (the graft is compressed within the delivery system).A cook representative met with the physicians involved with this complaint on 06 october 2016 to discuss the investigation findings and train the physicians on the product characteristics.According to the information received, the physicians understood and were satisfied with the investigation findings.The risk is acceptable.No further action is needed at this time.We will continue to monitor for similar events.
Event or Problem Description
During a aaa procedure, after the main body was placed, the 13 mm x 90 mm iliac leg graft was placed, but it was much too short.Intraoperative, the physician measured the leg graft in the x-ray with a centimeter sizing catheter.He measured a 74mm long leg instead of a 90mm leg.The leg implanted was a 13 mm x 74 mm and not a 13 mm x 90 mm.The label in the packaging was incorrect.The physician implanted an additional leg extension to reach the proper length.The physician implanted an additional leg extension to reach the proper length.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5721108
• Report Number: 1820334-2016-00410
• Device Sequence Number: 18906906
• Product Code: MIH
• UDI-Device Identifier: 10827002552330
• UDI-Public: (01)10827002552330(17)190131(10)6533427
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZSLE-13-90-ZT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 80 YR