MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1011915-080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 01/30/2024

Event Type  Injury  

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2022 the 6.0x8 mm absolute pro stent was implanted in the right distal superficial femoral artery.On (b)(6) 2024 the patient had restenosis in the stented segment, which the physician has deemed as related to non-compliance with the prescribed dual antiplatelet therapy (dapt) of aspirin and clopidogrel.This led to critical ischemia in the extremity.The patient was re-admitted to the hospital and the restenosis was successfully treated with atherectomy and implantation of a stent graft.Although the physician has deemed the restenosis to be related to the non-compliance with dapt, this will be conservatively reported for restenosis of the absolute pro stent.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of restenosis of stented segment is listed in the absolute pro.035 peripheral self-expanding stent system instructions for use as an adverse events that may be associated with the use of a stent in peripheral arteries and / or biliary tree.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.Additionally, per the physician, the reported stenosis appears to be unrelated to the device or the procedure as the patient failed to regularly take the prescribed dual antiplatelet medication.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO .035 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: 18978520
• MDR Text Key: 338597300
• Report Number: 2024168-2024-03653
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08717648114748
• UDI-Public: (01)08717648114748(17)251031(10)2110261
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1011915-080
• Device Lot Number: 2110261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 60 KG