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

Catalog Number	1012534-40
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.The investigation determined that the reported difficulties appear to be 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 patient underwent a peripheral procedure to treat a target lesion in the superficial femoral artery (sfa).The absolute pro vascular stent delivery system was advanced into the patient anatomy, but was unable to advance over the steep bifurcation at the common iliac artery.An attempt was made to remove the stent delivery system; however, resistance was noted and the stent deployed in the common iliac artery, while still in the lock position and without initiation of the thumbwheel to deploy.The stent was noted to be well apposed to the vessel wall at several points and no additional intervention was performed.The target lesion was treated with a non-abbott stent.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: 7380006
• Report Number: 2024168-2018-02268
• Device Sequence Number: 13757051
• Product Code: NIO
• UDI-Device Identifier: 08717648175985
• UDI-Public: 08717648175985
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: 08/31/2020
• Device Catalogue Number: 1012534-40
• Device Lot Number: 7092261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/28/2018
• 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
• Patient Age: 70 YR
• Patient Weight: 73