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

Model Number	1012535-40
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.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 prior to use in the patient during removal of the stylet, some resistance was felt and the tip stuck to the stylet.During stylet removal, the 7.0x40 mm absolute pro stent began deploying.Two cells of the stent were deployed.Since there was no patient involvement, another same size absolute pro was used to complete the procedure without further incident.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to remove and the reported activation failure were able 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during unpackaging and/or preparation for use inadvertent mishandling resulted in the noted bent jacket and strain relief distal to the handle; thus resulting in the reported difficult to remove stylet.Manipulation in attempts to remove the stylet inadvertently resulted in the reported premature activation/deployment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12422430
• Report Number: 2024168-2021-07867
• Device Sequence Number: 3308524
• Product Code: NIP
• UDI-Device Identifier: 08717648176067
• UDI-Public: 08717648176067
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 10/04/2021

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: 04/30/2022
• Device Model Number: 1012535-40
• Device Catalogue Number: 1012535-40
• Device Lot Number: 9052161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1