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

Model Number G48428

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Device is available for evaluation but has not yet been received by the manufacturer.(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that upon opening the zenith flex aaa endovascular graft bifurcated main body in the sterile field, the physician noticed what appears to be a hair stuck in the peel away.A new device was used to complete the procedure.There were no adverse effects to the patient reported.

Manufacturer Narrative

Investigation/evaluation: the actual complaint device was returned and a visual inspection was performed.A review of the device history record, complaint history, and quality control data was also conducted.Reviewing the images of the complaint device revealed the presence of a dark fiber contained within the peel away sheath.The device was returned for analysis.The visual inspection of the device found no foreign matter on the device.It is likely that the fiber detached during shipping and or handling back to the manufacturer.The device history record was reviewed and no non-conformances were noted.A review of complaint history records revealed this complaint to be the only reported complaint associated with the complaint lot number 7776100.Each device is shipped with instruction for use (ifu) listing the indications for use, contraindications, warnings and precautions.It is feasible to suggest the foreign matter was introduced during a manufacturing process.Per the quality engineering risk assessment, no further action is required.The appropriate cook personnel have been notified of this event.Monitoring will continue to be performed for similar complaints.

• 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 ; 8123392235
• MDR Report Key: 7154937
• MDR Text Key: 96113505
• Report Number: 1820334-2017-02063
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484280
• UDI-Public: (01)10827002484280(17)190405(10)7776100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48428
• Device Catalogue Number: TFFB-32-96-ZT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• 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