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

Catalog Number 1011920-100

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Material Separation (1562)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous lesion in the superficial femoral artery (sfa).A 5.0x100mmx135cm absolute pro absolute pro self-expanding stent system (sess) was advance over a 300cm non-abbott guide wire (gw) and attempted to be inserted into a non-abbott 6f sheath, however, the tip of the stent became stuck in the 6f sheath valve, and the stent could not be advanced.The absolute stent was then removed from the gw with significant resistance.Subsequently, the 6f sheath was then removed from the gw, and the tip of the absolute stent was detached and lodged in the 6f sheath valve.A new 6f sheath was advanced over the 300cm non-abbott gw, the 300cm gw was removed and replaced with a 300cm supracore gw, and a new absolute pro stent of the same size was used to successfully complete the procedure.The surgeon noted the sheath valve could have been the issue.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned for analysis.The reported tip material separation was able to be confirmed.The reported difficult to insert, the reported difficult to remove-introducer sheath, and the reported difficult to remove-guide wire 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 interaction with the noted collapsed shaft of the non-abbott introducer sheath resulted in the reported difficult to insert and the reported difficult to remove.Manipulation of the device resulted in the noted bunched sheath, the noted multiple sheath wrinkles and ultimately resulted in the reported/noted tip material separation.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: 17333440
• MDR Text Key: 319452292
• Report Number: 2024168-2023-07595
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011920-100
• Device Lot Number: 3030161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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