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

Model Number	1012534-40
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned device.The premature deployment and deformed stent were confirmed as the stent was returned partially deployed and was deformed with stretched, flared and bent struts.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 was unable to determine a cause for the reported premature deployment.It may be possible that the distal sheath of the sess kinked (as noted on the returned unit) causing the distal sheath to slightly retract resulting in the stent partially expanding at the distal end; however, this could not be confirmed.The damage to the partially deployed stent likely occurred as the stent system was pulled back into the sheath with the stent partially expanded (flowered).There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the superficial femoral artery that was heavily tortuous.When the absolute pro stent delivery system (sds) reached the target lesion, it was observed that 10mm of the stent was sticking out of the sheath.The physician decided to pull the sds back into the sheath and remove from the patient.At that point, it was noted that the stent was damaged.There was no reported adverse patient effect and no clinically significant delay in the procedure.Another absolute pro was used to successfully complete the procedure.No additional information was provided.

• 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: 11405564
• Report Number: 2024168-2021-01678
• Device Sequence Number: 14360485
• Product Code: NIP
• UDI-Device Identifier: 08717648175985
• UDI-Public: 08717648175985
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: 06/30/2023
• Device Model Number: 1012534-40
• Device Catalogue Number: 1012534-40
• Device Lot Number: 0071461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1