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

Catalog Number 42075020-120

Device Problem Device Damaged by Another Device (2915)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 07/23/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the information provided, the reported difficulties and subsequent patient effects appear to be due to circumstances of the procedure.The device damaged by another device (stent movement) was the result of the introducer sheath interacting with the stent while attempting to cross during the second procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported the original procedure was performed on (b)(6) 2021 to treat a lesion in the left common femoral artery (cfa).The 7.50x20mm supera self expanding stent system (sess) was advanced to the target lesion and the stent deployed.The stent was confirmed to be well apposed to the vessel wall.A second procedure was performed on (b)(6) 2021 to treat the lower limb and the same access site puncture was used.While advancing the 6fr introducer sheath, it crossed the supera stent and caused the stent to move towards the superficial femoral artery (sfa).The procedure was continued and the patient was treated successfully.The supera stent remained in the sfa however the stent was not damaged and the final patient outcome was good.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• 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: 12263028
• MDR Text Key: 264700162
• Report Number: 2024168-2021-06732
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42075020-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• 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