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

Model Number 1012535-100

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Device code (b)(4).Visual analysis was performed on the returned device.The reported difficulties were unable to be confirmed as the stent was already fully deployed.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 revealed no indication of a lot specific product quality issue.It should be noted that the absolute pro instruction for use states: should unusual resistance be felt at any time, including resistance unlocking the handle or rotating the thumbwheel, during stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Failure to follow these instructions could result in failure to deploy, difficulties with deployment, partial stent deployment or deployment in an unintended location.In this case, it does not appear that the use of extra force to rotate the thumbwheel and deploy the stent contributed to the difficulty, as the stent was ultimately deployed.In addition, with the stent already partially deployed, the stent system would not be able to be removed together with the introducer sheath or guiding catheter as a single unit without causing damage to the stent.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that the distal shaft was bent or restricted in the anatomy (possibly at the aortic bifurcation) preventing the shaft lumens from moving freely and causing resistance with the thumbwheel.The chatter marks noted throughout the entire length of the distal sheath of the returned unit are consistent with the sheath being bent over a tight radius, further suggesting that anatomical conditions may have contributed to the difficulties encountered; 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.Na.

Event Description

It was reported that the procedure was to treat a moderately calcified iliac artery.During deployment of a 7.0x100mm absolute pro stent, resistance was met when turning the thumbwheel and the stent was partially deployed.Extra force had to be applied to successfully deploy the stent at the intended site.There were no adverse patient effects and no clinically significant delay.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: 11389050
• MDR Text Key: 238598211
• Report Number: 2024168-2021-01525
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176098
• UDI-Public: 08717648176098
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 0072263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2020
• 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
• Patient Age: 47 YR
• Patient Weight: 110