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

Model Number 1012536-40

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

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 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
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11606028
• MDR Text Key: 244619139
• Report Number: 2024168-2021-02653
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176142
• UDI-Public: 08717648176142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1