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

Catalog Number 1011920-080

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

Patient Problem Stenosis (2263)

Event Date 09/28/2023

Event Type  Injury  

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2022 two absolute pro (5x80, 5x40) stents were implanted in the heavily calcified, distal right superficial femoral artery.On (b)(6) 2023, there was restenosis of the stented segment.The patient was re-admitted to the hospital.Treatment consisted of percutaneous transluminal angioplasty with a drug coated balloon dilatation catheter and atherectomy.Another stent was implanted distal from the target study stent.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.The reported patient effect of restenosis is listed in the absolute pro.035 peripheral self-expanding stent system instructions for use (ifu) as an adverse event that may be associated with the use of a stent in peripheral arteries and / or biliary tree.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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: 18994709
• MDR Text Key: 338828127
• Report Number: 2024168-2024-03832
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08717648115042
• UDI-Public: (01)08717648115042(17)251031(10)2111661
• 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: 03/28/2024

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: 1011920-080
• Device Lot Number: 2111661
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2022
• 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: ABSOLUTE PRO 5 X 40 , PART # 1011920-040, LOT # 21
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 65 KG