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

Lot Number UNKNOWN SUPERA

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/09/2023

Event Type  malfunction  

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 was not provided.It should be noted that the supera peripheral stent system instructions for use (ifu) states after initial stent deployment: rotate the deployment lock to the unlocked position.The investigation determined the reported difficulties appear to be related to deviation if the instructions for use and subsequent circumstances of the procedure as it is likely that as the deployment lock was not rotated to the unlock position the stent was not fully released from the device; thus when retracting the delivery system the stent came with the system and got stuck on the introducer sheath.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion in and unspecified artery.The supera self-expanding stent system (sess) was advanced to the target lesion and the stent was released from the delivery system; however, the physician did not unlock the deployment lock before attempting to remove the delivery system.Therefore, the stent was pulled back with the delivery system and became stuck with introducer sheath.The stent was able to be removed from the catheter.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another supera stent was implanted to complete 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: 17034858
• MDR Text Key: 316304415
• Report Number: 2024168-2023-05699
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• 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