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

Model Number 1012534-40

Device Problems Premature Activation (1484); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Visual and functional inspection was performed on the returned device.The premature deployment and deformed stent were confirmed as the stent was returned partially deployed and was deformed with stretched, flared and bent struts.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 premature deployment.It may be possible that the distal sheath of the sess kinked (as noted on the returned unit) causing the distal sheath to slightly retract resulting in the stent partially expanding at the distal end; however, this could not be confirmed.The damage to the partially deployed stent likely occurred as the stent system was pulled back into the sheath with the stent partially expanded (flowered).There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion located in the superficial femoral artery that was heavily tortuous.When the absolute pro stent delivery system (sds) reached the target lesion, it was observed that 10mm of the stent was sticking out of the sheath.The physician decided to pull the sds back into the sheath and remove from the patient.At that point, it was noted that the stent was damaged.There was no reported adverse patient effect and no clinically significant delay in the procedure.Another absolute pro was used to successfully complete 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: 11405564
• MDR Text Key: 239209579
• Report Number: 2024168-2021-01678
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648175985
• UDI-Public: 08717648175985
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1012534-40
• Device Catalogue Number: 1012534-40
• Device Lot Number: 0071461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• 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