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

Catalog Number UNK SUPERA

Device Problem Off-Label Use (1494)

Patient Problems Ischemia (1942); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 02/10/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a calcified common femoral artery.The patient had a previously unspecified supera stent implanted, and the patient began to experience critical ischemia.Thrombosis was noted via angiogram.Surgery was performed to remove the supera stent, and some tissue was noted on the stent.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The udi number is not known as the part and lot number were not provided.(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 were not provided.Reportedly, the procedure was to treat a calcified common femoral artery.It should be noted that the supera peripheral stent system instructions for use (ifu) states: the supera peripheral stent system is indicated for peripheral vascular use.It is undermined if the deviation of the ifu caused/contributed to the reported patient effects.The reported patient effects of thrombosis and transient ischemic attack are listed in the supera peripheral stent system instructions for use as potential adverse effects of peripheral percutaneous intervention.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.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: 14347581
• MDR Text Key: 291308427
• Report Number: 2024168-2022-05094
• 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,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• 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): Required Intervention; Hospitalization