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

Model Number	1012529-60
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported activation failure, and mechanical jam were confirmed.Additionally, it was noted that the stent implant was exposed 5mm from the distal end of the sheath.The retractable sheath was torn sporadically proximal to the sheath.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 incidents.The investigation was unable to determine a cause for the reported deployment difficulty and removal difficulty.Based on the reported information, it may be possible that the anatomical conditions induced the distal shaft sheath damage as noted on the returned unit during the insertion process or during the activation, causing partial deployment and the inability to release the stent from the delivery system; 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 devicena.
Event or Problem Description
It was reported that the procedure was to treat a right external iliac artery via left groin access.The 7x60mm absolute pro vascular self-expanding stent system (ses) was advanced to the lesion and unlocked however the thumb wheel would not rotate, therefore the stent was not implanted.The device was removed without issue.Another absolute pro ses was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in 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: 11396919
• Report Number: 2024168-2021-01599
• Device Sequence Number: 19713765
• Product Code: NIP
• UDI-Device Identifier: 08717648175633
• UDI-Public: 08717648175633
• 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
• 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): 03/01/2021

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: 02/28/2023
• Device Model Number: 1012529-60
• Device Catalogue Number: 1012529-60
• Device Lot Number: 0030961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1