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

Model Number	1012535-80
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned device.The premature deployment was confirmed as the device was returned with the stent fully deployed out of the delivery system.The difficult to advance into the introducer sheath was not tested due to the condition of the returned device.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 difficulties.It may be possible that the introducer sheath was bent or collapsed causing resistance during advancement and resulting in the distal sheath of the absolute pro to slightly retract resulting in partial stent deployment; however, this could not be confirmed.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 7x8mm absolute pro self-expanding stent (ses) was being advanced to the target lesion when the stent deployed in the introducer sheath.The issue was noted when the device was removed from the anatomy, to figure out why it would not advance.Another absolute pro was used without issue 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: 12734157
• Report Number: 2024168-2021-09839
• Device Sequence Number: 4560673
• Product Code: NIP
• UDI-Device Identifier: 08717648176081
• UDI-Public: 08717648176081
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/01/2021

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: 04/30/2024
• Device Model Number: 1012535-80
• Device Catalogue Number: 1012535-80
• Device Lot Number: 1051261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1