MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	VAMC3030C150TU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft system was planned to be implanted in a patient for the endovascular treatment of a 250 mm thoracic dissection.It was reported that when the product was opened it the side port on the device was detached from the delivery system.The physician reported that the device was broken.It was noted that there was no damage to the sterile packaging or box on inspection.A different valiant stent graft system was used and the event was resolved.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the device and detached side port were returned for analysis.The side port length was measured at 7.5 inch; specification is 7.50 +/- 0.50 inch.There was no elongation evident to the side port tubing.The side port extension was broken off at the base of the barbed adaptor.The break point was uneven.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7487506
• Report Number: 2953200-2018-00649
• Device Sequence Number: 1339701
• Product Code: MIH
• UDI-Device Identifier: 00643169346598
• UDI-Public: 00643169346598
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2018
• Device Model Number: VAMC3030C150TU
• Device Catalogue Number: VAMC3030C150TU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 08/08/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 07/26/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1