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

Catalog Number 1012014-150

Device Problems Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional devices referenced in b5 are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat the 100% stenosed left superficial femoral artery (sfa) with moderate calcification and minimal tortuosity.Pre-dilatation was performed with a 5x120 mm armada percutaneous transluminal angioplasty (pta) catheter and a dissection was caused; however, this was a controlled process and the dissection was treated with a balloon dilatation catheter.The 5x150 mm absolute pro self expanding stent system (sess) was advanced to the lesion.Upon attempting deployment, there was stickiness in the thumbwheel.The stent partially deployed and a portion of the stent separated.The delivery system was removed as a single unit but a portion of the stent remained in the lumen of the artery, in front of the target lesion.A 5x120 mm armada pta catheter was used to inflate the separated portion of the stent.After the unsuccessful deployment of the first stent, a second, same size absolute pro sess was advanced to the lesion.During the attempt to deploy the stent, the thumbwheel jammed and the stent began to deploy in a deformed way.The delivery system was removed with the stent.There was no adverse patient sequela.No additional information was provided.

Event Description

It was reported that the procedure was to treat the 100% stenosed left superficial femoral artery (sfa) with moderate calcification and minimal tortuosity.Pre-dilatation was performed with a 5x120 mm armada percutaneous transluminal angioplasty (pta) catheter and a dissection was caused; however, this was a controlled process and the dissection was treated with a balloon dilatation catheter.The 5x150 mm absolute pro self expanding stent system (sess) was advanced to the lesion.Upon attempting deployment, there was stickiness in the thumbwheel.The stent partially deployed and a portion of the stent separated.The delivery system was removed as a single unit but a portion of the stent remained in the lumen of the artery, in front of the target lesion.A 5x120 mm armada pta catheter was used to inflate the separated portion of the stent.After the unsuccessful deployment of the first stent, a second, same size absolute pro sess was advanced to the lesion.During the attempt to deploy the stent, the thumbwheel jammed and the stent began to deploy in a deformed way.The delivery system was removed with the stent.There was no adverse patient sequela.Subsequent to the initially filed mdr, it was reported that the first armada used was an armada 35.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 did not indicate a lot specific quality issue.As there was no damage noted to the device during the inspection prior to use, it is possible that the distal shaft was bent by the moderately calcified and minimally torturous anatomy preventing the shaft lumens from moving freely, resulting in resistance with the thumbwheel and difficulty deploying the stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation failure and the reported mechanical jam cannot be determined.Interaction and/or manipulation of the compromised device likely resulted in the reported stent material separation.The treatment appears to be related to the operational context of the procedure as a 5x120 mm armada pta catheter was used to inflate the separated portion of the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 17716788
• MDR Text Key: 323038061
• Report Number: 2024168-2023-09832
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 1012014-150
• Device Lot Number: 0091461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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
• Treatment: .035 MERIT GUIDE WIRE
• Patient Outcome(s): Required Intervention