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

Model Number S-65-040-120-P6

Device Problems Activation Failure (3270); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/06/2023

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 incidents from this lot.The investigation determined the reported activation/deployment failure appears to be related to circumstances of the procedure as it is likely that the during stent deployment the introducer sheath was too close to the proximal end of the stent; thus resulting in the stent to partially deploy into the introducer sheath.As reported, when the sheath was pulled the stent moved into the common femoral/external iliac artery and remains there; thus resulting in the reported migration.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 the 6.5 mm proximal superficial femoral artery with no calcification or tortuosity.The vessel was prepared with a 7x40 mm balloon.Atherectomy was not used.The 6.5x40 mm supera self expanding stent (ses) partially (about 5 mm) deployed in the sheath.When the sheath was pulled, the stent moved into the common femoral/external iliac artery and remains there.This is an unintended location.The target lesion was not treated.

• 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: 16448579
• MDR Text Key: 310321125
• Report Number: 2024168-2023-01996
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: 08717648226229
• 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: 02/27/2023

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 Model Number: S-65-040-120-P6
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 2111161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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
• Treatment: .014 GUIDE WIRE; 6FR 45 CM SHEATH
• Patient Outcome(s): Other