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

Catalog Number UNK SUPERA

Device Problem Stretched (1601)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

B3: date of event estimated d4: the udi number is not known as the part and lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported on social media by a physician that supera stents get occluded due to the stent elongating during deployment.Atherectomy was done and some balloon dilatation catheters (bdc) were used for re-opening the lesion.The patient was well and released.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effect of occlusion is listed in the supera peripherial stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.A conclusive cause for the reported patient effect, 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.It is possible that the stent is oversized for the artery and/or pre-dilatation was not enough in some locations causing the stent to stretch/elongate during deployment; however, this could not be confirmed.The investigation determined a conclusive cause for the reported stretched-stent cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported on social media by a physician that supera stents get occluded due to the stent elongating during deployment.Atherectomy was done and some balloon dilatation catheters (bdc) were used for re-opening the lesion.The patient was well and released.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.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: 18183725
• MDR Text Key: 328691219
• Report Number: 2024168-2023-12948
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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: 10/31/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/21/2023
• 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): Required Intervention; Hospitalization