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

Model Number 42055100-080

Device Problem Break (1069)

Patient Problem Ischemia (1942)

Event Date 01/31/2024

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 reported patient effect of ischemia is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.A cine was received and reviewed by an abbott vascular clinical specialist: it was reported that at a 3 month follow-up, a break in an supera stent implanted in the popliteal artery was discovered.The image provided clearly shows a fracture in the supera stent at the knee joint.A specific cause of the stent fracture is not able to be determined.Bending at the joint would be a likely contributing factor.It is possible that bending at the knee joint and/or stress/fatigue/repetitive movement due to anatomical conditions resulted in the reported stent break; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The reported difficulties possibly caused/contributed to the reported patient effects, however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure as reportedly revascularization was performed with balloon angioplasty and a new 5.5x150mm supera stent was implanted.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2023, the patient underwent a peripheral stenting procedure, treating a lesion in the popliteal artery with implant of the 5.5x100 mm supera self expanding stent (ses).During the patient's 3 month follow up physician appointment on 01/31/2024, the patient presented with critical limb ischemia.It was noted that the implanted 5.5x100mm supera stent had a break.Re-vascularization was performed with balloon angioplasty and implant of a new 5.5x150mm supera stent.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: 18762739
• MDR Text Key: 336051929
• Report Number: 2024168-2024-02273
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42055100-080
• Device Catalogue Number: SES
• Device Lot Number: 3022161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female