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

Catalog Number UNK SUPERA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Ischemia (1942); Thrombosis/Thrombus (4440)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number was not provided.Reportedly, it was noted the vessel diameter is 9mm and the supera stent is 6mm.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatments appears to be related to the operational context of the procedure as thrombolytic therapy and angioplasty was preformed.It should be noted that the supera peripheral stent system instructions for use states: the stent sizes are labeled based on the outer stent diameter.A stent should initially be chosen such that its labeled diameter matches the reference vessel diameter (rvd) proximal and distal to the lesion.Final stent selection should be confirmed after lesion pre-dilation: if possible, the stent diameter should match the prepared lesion diameter 1:1.Choosing a labeled diameter to match the reference vessel diameter, then appropriately preparing the vessel to match that stent¿s diameter will result in a stent that is properly sized to the vessel.The deviation of the instructions for use likely contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.Dates estimated literature attachment: article title: "using undersized supera in the superficial femoral artery as a coil.".

Event Description

During a presentation of a case regarding a 71 year old male patient that was complaining of claudication in the right leg was noted to have a total occlusion of the proximal superficial femoral artery (sfa).Percutaneous transluminal angioplasty and atherectomy was preformed with a non-abbott catheter.A 6.0x12mm supera stent was deployed in the right sfa.The patient present to the hospital with acute right leg ischemia on the same day and thrombolytic therapy and angioplasty was preformed.It was noted the vessel diameter is 9mm and the supera stent is 6mm.There was no adverse patient sequela and no clinically significant delay reported.One week later, the patient was re-admitted with acute right leg ischemia due to thrombosis of the supera stent.Patient was referred for femoral popliteal artery bypass surgery.No additional information was provided.

• Brand Name: SUPERA
• 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: 17242739
• MDR Text Key: 318240674
• Report Number: 2024168-2023-07015
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Disability; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male