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

Catalog Number UNK SUPERA

Device Problem Premature Activation (1484)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that the procedure was performed to treat a lesion in the mildly tortuous and mildly calcified lesion in the superficial femoral artery (sfa).The vessel diameter was 5.5 mm and atherectomy was not used.A.018 5.5x150 mm armada percutaneous transluminal angioplasty (pta) catheter was used to prepare the lesion for 2 minutes.The supera self-expanding stent system (sess) was prepared per the instructions for use.The sess was advanced without issues; however, when attempting to deploy the stent it prematurely deployed before the second red lever was activated to release the stent.The stent was deployed at the intended site.The procedure was successfully completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.An exception review was performed and revealed no indication of a product quality issue.Additionally, an electronic lot history record (lhr) review and review of the complaint handling database could not be conducted because the part and lot number were not provided it is possible that during deployment, prior to unlocking the deployment lock, the delivery system was inadvertently pulled back slightly resulting in full deployment of the stent; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 19013022
• MDR Text Key: 339092785
• Report Number: 2024168-2024-03964
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 6FR 45CM DESTINATION SHEATH