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

Catalog Number 42055200-120

Device Problems Stretched (1601); Difficult or Delayed Activation (2577); Defective Device (2588); Physical Resistance/Sticking (4012)

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

Event Date 02/23/2024

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 the superficial femoral artery (sfa) with moderate calcification, mild tortuosity and 75% stenosis.The vessel diameter is 5 mm and atherectomy was not used.A command es guide wire crossed the lesion and then a 5.5x200 mm armada 18 percutaneous transluminal angioplasty (pta) catheter was used to pre-dilate the lesion.The 5.5x200 mm supera self expanding stent system (sess) was prepared per the instructions for use and was advanced to the lesion.Deployment was started and nearly 70% of deployment was complete when the thumbslide got stuck and the stent stopped deploying.The physician continued to try to slowly deploy the stent and it was able to be deployed completely; however, there was no uniformity in the stent for the remaining 30% and there were areas with stacking and elongation of the stent.The stent is in the target lesion.There were no adverse patient effects and there was a delay in the procedure; however, there was no harm to the patient.No additional information was provided.

• Brand Name: SUPERA 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: 18887387
• MDR Text Key: 337541560
• Report Number: 2024168-2024-03216
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42055200-120
• Device Lot Number: 3011261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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: 6MM 45 CM SHEATH; COMMAND ES GUIDE WIRE