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

Catalog Number 1011920-040

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

Patient Problem Stenosis (2263)

Event Date 10/28/2023

Event Type  Injury  

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2023, one 5.0x40 mm absolute pro stent was implanted in the left distal superficial femoral artery (sfa).On (b)(6) 2023, in-stent restenosis occurred in the stented segment of the distal sfa.The patient was re-admitted to the hospital and the restenosis was successfully treated with angioplasty using a drug coated balloon.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 effect of restenosis of stented segment is listed in the absolute pro.035 peripheral self-expanding stent system instructions for use as an adverse event that may be associated with the use of a stent in peripheral arteries and / or biliary tree.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.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: 19006259
• MDR Text Key: 338937256
• Report Number: 2024168-2024-03885
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08717648115028
• UDI-Public: (01)08717648115028(17)250930(10)2102562
• 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: 03/29/2024

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: 1011920-040
• Device Lot Number: 2102562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2022
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 75 KG