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

Model Number S-55-060-120-P6

Device Problems Break (1069); Difficult to Remove (1528); Stretched (1601); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal interaction between the deployed stent and the device tip resulted in the reported difficult to remove.Manipulation to remove the device resulted in the reported stretched stent and the reported stent migration.Inadvertent mishandling possibly resulted in the reported handle break; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported break.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 performed to treat a lesion in the popliteal artery.A 5.5x60mm supera self-expanding stent was deployed; however, during removal of the self-expanding stent system (sess) resistance between the stent and tip was felt.After several attempts the sess was able to be removed, but the stent elongated and moved approximately 5cm out of the target lesion into the femoral artery.It was further reported that the handle of the system was observed to be damaged with the middle part being open.The procedure was finished and nothing further was done.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: 16473997
• MDR Text Key: 310584905
• Report Number: 2024168-2023-02148
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: S-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 1080661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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