MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1011922-100

Device Problems Premature Activation (1484); Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.

Event Description

It was reported that the procedure was to treat a lesion in the left external iliac artery with mild calcification and mild tortuosity.The 7.0x100mm absolute pro.035 self-expanding stent system (sess) had resistance with the 6french (f) guiding catheter during advancement and it was noted that the gold segment of the delivery catheter was not sitting fully flush against the delivery tip.The sheath was becoming unsheathed and flowering.The sess including the exposed stent was managed to be pulled out of the guiding catheter independently but with resistance.A new guiding catheter and another 7.0x80mm absolute pro stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported premature activation was able to be confirmed.The reported difficult to advance 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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement the guiding catheter and the device were not coaxially aligned resulting in the reported difficult to advance and the reported difficult to remove.Interaction and/or manipulation of the device resulted in the noted device damages (multiple distal sheath wrinkles, wrinkled jacket stabilizer) compromising the device resulting in the distal sheath to slightly retract from the base of the tip, and thus inadvertently resulting in the reported/noted stent premature activation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO .035 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: 17950857
• MDR Text Key: 325968375
• Report Number: 2024168-2023-11431
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011922-100
• Device Lot Number: 3060661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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
• Treatment: 6F GUIDING CATHETER