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

Model Number	1012536-40
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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 and/or complaints from this lot.Based on the information provided, a conclusive cause for the reported difficulties could not be determined.It may be possible that the absolute pro stent was narrowed in the mid area or the armada 35 balloon was inflated to a diameter larger than that the absolute pro stent diameter resulting in the stent fracture; 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.The armada balloon dilatation catheter referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported the procedure was to treat an arteriovenous (av) fistula.The absolute pro was implanted in the fistula, without issue, and post dilated with an 8x40mm armada 35 balloon dilatation catheter (bdc).After post dilatation, the stent was noted to be fractured in the mid area.The vessel was opened up after post dilatation with the balloon; therefore, no additional treatment was needed and the fractured stent was left as is.The procedure was complete at this time.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: 11606028
• Report Number: 2024168-2021-02653
• Device Sequence Number: 16933951
• Product Code: NIP
• UDI-Device Identifier: 08717648176142
• UDI-Public: 08717648176142
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/01/2021

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: 05/31/2022
• Device Model Number: 1012536-40
• Device Catalogue Number: 1012536-40
• Device Lot Number: 9060661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1