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

Model Number	1012535-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of pain is listed in the absolute pro vascular self-expanding stent system instructions for use as a potential adverse effect (e.G., complication) that may be associated with the use of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional absolute pro vascular device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6)2023, the procedure was performed to treat lesions in both legs with a 7.0x60mm and 7.0x20mm absolute pro vascular self expanding stents system (sess) that were implanted successfully.On (b)(6)2023, the patient experienced severe leg pain.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 16872289
• Report Number: 2024168-2023-04736
• Device Sequence Number: 20291809
• Product Code: NIP
• UDI-Device Identifier: 08717648176074
• UDI-Public: 08717648176074
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012535-60
• Device Catalogue Number: 1012535-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female