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

Catalog Number 1012530-60

Device Problems Premature Activation (1484); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

B3, b6: dates are estimated.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that during the procedure, the guide wire was in the target lesion and the prepared absolute pro self-expanding stent system (sess) was being advanced over the guide wire, when the stent became exposed [started to deploy] prior to entering the introducer sheath.The sess was then attempted to be removed from the guide wire, however resistance was met and the outer sheath of the sess was noted as bunched up.They decided to deploy the stent on the guide wire in order to remove it.A new absolute pro stent was used successfully for the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deformation due to compressive stress was able to be confirmed.The reported premature activation and the reported difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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 incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement onto the guide wire inadvertent mishandling resulted in the reported bunched outer sheath/noted wrinkled sheath, the noted kinked/bunched inner member and the noted smashed/torn tip; thus compromising the device resulting in the reported premature activation and the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 18162966
• MDR Text Key: 328433346
• Report Number: 2024168-2023-12844
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648175718
• UDI-Public: 08717648175718
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012530-60
• Device Lot Number: 3060961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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