MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1012015-120

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/05/2022

Event Type  Injury  

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 thrombosis is listed in the absolute pro ll peripheral self-expanding stent system instructions for use as a possible vessel use complication.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments appear 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.

Event Description

Patient id: (b)(6).It was reported that the procedure was performed on (b)(6) 2021, treating a target lesion in the mildly calcified left superficial femoral artery.Pre-dilatation was performed and the 6.0 x 120 mm absolute pro ll stent was implanted.Post-dilatation was performed.On (b)(6) 2022, the patient was re-hospitalized with thrombosis in the implanted stent and necrosis of the toes on the left foot.On (b)(6) 2022, the patient underwent amputation of the 3rd, 4th and 5th toes, left foot.On (b)(6) 2022, thrombus aspiration and drug-coated balloon angioplasty was performed at the target lesion, as well as at the posterior tibial artery, iliac artery and popliteal artery, non-study vessels.On (b)(6) 2022, the patient underwent a second surgical procedure, with amputation of the 5th metatarsal of the left foot.The event resolved on (b)(6) 2022.No additional information was provided.

• Brand Name: ABSOLUTE PRO LL 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: 14440893
• MDR Text Key: 292521955
• Report Number: 2024168-2022-05394
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110028
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 1012015-120
• Device Lot Number: 9111261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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; Disability
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 67 KG