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

Catalog Number 1011915-040

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

Patient Problem Stenosis (2263)

Event Date 08/07/2023

Event Type  Injury  

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2022, three absolute pro stents (6.0x40, 6.0x120, 6.0x80) were implanted in the 100% stenosis in the mildly calcified, proximal left superficial femoral artery (sfa).On (b)(6) 2023, the patient had a persisting stenosis in the index vessel and a persisting pre-existing wound on the index leg.Decision was made to treat these.On (b)(6) 2023, the patient was re-admitted to the hospital.Surgical removal of the calcified stenosis was performed at the femoral bifurcation (index leg) and angioplasty of the sfa (index lesion) was performed.On (b)(6) 2023, a bedside abscess splitting of the persisting wound was performed.The patient condition has resolved.There was no device deficiency.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 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 treatments 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.The additional absolute pro devices referenced in b5 are filed under separate medwatch report numbers.

• 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: 17638200
• MDR Text Key: 322135927
• Report Number: 2024168-2023-09405
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 08/28/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1011915-040
• Device Lot Number: 2091261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 38 KG