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

Catalog Number	1012531-40
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.Visual and functional inspection was performed on the returned device.The deployment difficulty and inaccurate delivery issues were not confirmed as the stent was fully deployed and not returned.The inaccurate delivery was due to case circumstances.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 was unable to determine a conclusive cause for the reported difficulties.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 in the non-tortuous, moderately calcified 70% stenosed, proximal left external iliac artery.A 9.0 x 40 mm absolute pro vascular stent delivery system (sds) was selected for the procedure.The sds was advanced to the lesion and during deployment of the stent implant, the thumbwheel stopped turning and they decided to remove the sds from the anatomy.When they pulled the sds back into the sheath the stent deployed at the aortic bifurcation instead of the proximal left external iliac as intended.The stent was left in place and a omnilink stent was implanted in the proximal left external iliac to successfully complete the procedure.There was no reported clinically significant delay in the procedure.No additional information 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: 6966293
• Report Number: 2024168-2017-08366
• Device Sequence Number: 13574035
• Product Code: NIO
• UDI-Device Identifier: 08717648175787
• UDI-Public: 08717648175787
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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: 11/30/2019
• Device Catalogue Number: 1012531-40
• Device Lot Number: 6120661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other