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

Catalog Number 1012016-150

Device Problems Break (1069); Mechanical Jam (2983); Activation Failure (3270); Material Split, Cut or Torn (4008)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a de novo lesion in the superficial femoral artery (sfa) with 80% stenosis, mild calcification and no tortuosity.The 7.0x150mm absolute pro ll self-expanding stent system (sess) could not be deployed as the thumbwheel could not be turned.Another same size absolute pro ll stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.***returned device analysis identified that the inner member was torn and there was a break in the shaft.The account was not aware of the tear or the break in the shaft.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam was able to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.Additionally, the analysis noted the inner member was torn and there was a break in the shaft.Follow-up with the site was performed; however, the site was not aware of the tear or the break in the shaft.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 interaction with the 80% stenosed anatomy and/or inadvertent mishandling resulted in the noted multiple device damages (kinked stent, overlapped stent struts/ connector, kinked/wrinkled sheath, kinked inner member, kinked and wrinkled jacket stabilizer/outer member, cracked jacket stabilizer) thus preventing the shaft lumens from moving freely resulting in the reported thumbwheel difficulties and ultimately resulting in the reported difficulty deploying the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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
• 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: 17692957
• MDR Text Key: 322766760
• Report Number: 2024168-2023-09675
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110028
• 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
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012016-150
• Device Lot Number: 2072761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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: TERUMO035 GUIDEWIRE