MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TFFB-30-96-ZT

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported device is not available for evaluation and has been discarded.

Event Description

It was reported during an endovascular aneurysm repair procedure using a zenith flex aaa endovascular graft bifurcated main body, the physician and representative believe that there was a suture hole in the first seal stent of the graft.A leak of contrast was seen outside of the graft where a suture hole would be.A cuff was added to cover the hole and the leak was no longer present.The patient did require an additional procedure due to this occurrence.The product caused or contributed to the need for an additional procedure.An additional cuff was implanted.

Manufacturer Narrative

510(k) p020018.Investigation: a review of complaint history, device history record, instructions for use, trends, and quality control data was conducted during the investigation.Zenith flex aaa endovascular graft bifurcated main body was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.Review of the device history record shows no nonconforming events which could contribute to this failure mode.There were no other reported complaints for this lot number.Based on the investigation evaluation, there is no indication that the a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing and quality controls that may have contributed to this incident.Based on the available information and the investigation results, a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6682293
• MDR Text Key: 78897322
• Report Number: 1820334-2017-01418
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484235
• UDI-Public: (01)10827002484235(17)170913(10)6181190
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TFFB-30-96-ZT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Date Device Manufactured: 09/13/2015
• 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: 58 YR