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

Model Number	1012535-20
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar incidents.The investigation was unable to determine a cause for the reported deployment issue.It may be possible that the distal sheath was bent or entrapped within the vessel causing the deployment difficulty; however, this could not be confirmed.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 a 7.0x20mm absolute pro self-expanding stent was unable to be fully deployed due to resistance with the thumbwheel.The stent and stent system were removed.The procedure was successfully completed with the deployment of a non-abbott stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Additional information: the procedure was a femoral to femoral crossover to treat a 70% calcified lesion in the right superficial femoral artery and right tibial-peroneal trunk.No additional information was provided.
Additional Manufacturer Narrative
Updated information: the investigation was unable to determine a cause for the reported deployment issue.It may be possible that the distal sheath was bent or entrapped over the aortic bifurcation causing the deployment difficulty; however, ultimately this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9750890
• Report Number: 2024168-2020-01752
• Device Sequence Number: 16926384
• Product Code: NIP
• UDI-Device Identifier: 08717648176043
• UDI-Public: 08717648176043
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 03/31/2022
• Device Model Number: 1012535-20
• Device Catalogue Number: 1012535-20
• Device Lot Number: 9040261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1