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

Catalog Number UNK SUPERA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 07/19/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023 the patient presented with intermittent claudication and a totally occluded supera stent in the popliteal artery was noted.The stent had been implanted approximately 2 months prior.No treatment has been performed.No additional information was provided.

Manufacturer Narrative

D4: the udi is unknown due to the part/lot number was not provided.D6a: implant date is estimated.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.The reported patient effect of occlusion and pain are listed in the supera peripheral stent system instructions for use as potential adverse events associated to the use of the device.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 17552718
• MDR Text Key: 321221156
• Report Number: 2024168-2023-08820
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: DR
• 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: 08/15/2023

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?: No
• 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: 07/21/2023
• Initial Date FDA Received: 08/15/2023
• 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): Other
• Patient Sex: Male