MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	1012535-80
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: estimated.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a percutaneous intervention was being performed on the superficial femoral artery lesion.An absolute pro stent delivery system (sds) advanced without issue to the lesion site.During stent deployment, a strange noise was heard, however, there was no issue with deployment, no unusual resistance noted, and the stent was successfully implanted.After stent implantation and during absolute pro delivery system removal, resistance was noted with the wire.The absolute pro delivery system and wire were removed as a single unit.The stent remained successfully implanted and there was no adverse patient effect.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned product.The reported noise and difficulty removing the absolute pro from the guide wire was unable to be confirmed.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 identified no other complaints reported from this lot.The investigation determined that the reported difficulties appear to be due to circumstances of the procedure.It is possible that the tip of the absolute pro became caught in the stent struts causing the noted tears around the base of the tip and the reported noise heard.Additionally, the reported resistance with the guide wire during removal was likely due to the clearance between the absolute pro guide wire lumen and outer diameter of the guide wire becoming reduced or kinked causing resistance.There was no resistance noted during advancement and no difficulties reported during deployment suggesting that the difficulties were due to circumstances of the procedure post-deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11178172
• Report Number: 2024168-2021-00479
• Device Sequence Number: 2993900
• Product Code: NIP
• UDI-Device Identifier: 08717648176081
• UDI-Public: 08717648176081
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 09/30/2022
• Device Model Number: 1012535-80
• Device Catalogue Number: 1012535-80
• Device Lot Number: 9102961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1