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

Catalog Number 1012014-150

Device Problems Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

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

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the superficial femoral artery that was moderately calcified and mildly stenosed.The absolute pro ll stent deployment wheel failed in the last 2 cms of the deployment; however, full deployment was achieved by pulling the sheath as the wheel wouldn't turn further.The stent was then deployed in the patient.There was no report of an adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported delayed activation was not tested based on the device condition as the stent was fully deployed.The reported physical resistance was also not tested based on condition.There was noted wrinkles throughout the sheath consistent with case circumstances.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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the distal shaft was bent or restricted in the anatomy preventing the shaft lumens from moving freely and causing the resistance with the thumbwheel; however, this could not be confirmed.The sheath was pulled to deploy the stent and as such likely contributed to the noted wrinkles on the stent sheath.The additional treatment is due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11298853
• MDR Text Key: 230919308
• Report Number: 2024168-2021-01001
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 1012014-150
• Device Lot Number: 0081861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention