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

Catalog Number	1012531-60
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.It is likely that the distal sheath was entrapped or bent within the heavily calcified and heavily tortuous anatomy such that further deployment was restricted.Additionally, removing the delivery system with the stent partially apposed to the vessel wall caused the difficulty removing and stent separation.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 that the reported difficulties are 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 a lesion located in the heavily calcified, heavily tortuous, right external iliac with a absolute pro vascular stent.Access was through the left common femoral artery using an up and over technique.Pre-dilatation with the balloon did not fully expand the heavily calcified lesion and there was a steep carina due to tortuosity.During stent deployment, approximately 1/3 of the stent deployed easily, but then the system locked up and the stent could not be deployed any further.The decision was made to remove the delivery system; however, in the process of removal, due to resistance felt, the stent implant fractured leaving part in the right iliac and part in the left iliac artery.Two stents were deployed over each segment of the fractured stent pinning the fracture stent pieces to the vessel wall.The stents also served to cover the intended lesion treating the lesion.The patient is reported to be stable.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: 7574463
• Report Number: 2024168-2018-04199
• Device Sequence Number: 13939639
• Product Code: NIO
• UDI-Device Identifier: 08717648175794
• UDI-Public: 08717648175794
• 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): 06/06/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 1012531-60
• Device Lot Number: 7102461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: GLIDEWIRE ADVANTAGESHEATH: TERUMO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 120