MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	1012536-30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspection was performed on the returned device.The premature deployment and difficulty removing were not confirmed as the stent had already been fully deployed.It is likely that the stent became exposed from the distal sheath during removal resulting in interaction between the introducer sheath and stent.Further retraction of the delivery system with the exposed stent likely caused the premature deployment.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined the difficulties were likely due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the left external iliac artery that did not have any tortuosity or calcification.The access site was the right femoral artery.An 8.0 x 30 mm absolute pro vascular self-expanding stent system crossed the lesion and then was removed in order to pre-dilate the lesion with an unspecified balloon catheter.The device did not meet any resistance when advancing towards the lesion.However, when the device was being removed over an unspecified guide wire, the stent got caught with the valve of an unspecified introducer sheath outside of the anatomy, and deployed over the guide wire.The device was never unlocked and the thumbwheel was not manipulated at all.An unspecified absolute pro stent was then used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6974826
• Report Number: 2024168-2017-08434
• Device Sequence Number: 16314832
• Product Code: NIO
• UDI-Device Identifier: 08717648176135
• UDI-Public: 08717648176135
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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: 04/30/2020
• Device Catalogue Number: 1012536-30
• Device Lot Number: 7051061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1