MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Introducer Kit ¿ 30 cm; Introducer, Catheter

Model Number	LSN25301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an aveir dr implant procedure on a congenital patient, the physician elected to start the procedure with the right atrium leadless pacemaker (ralp).The ralp was released at the target location.When attempting to manipulate the right ventricle leadless pacemaker (rvlp) with the delivery catheter into the rv, the catheter mechanically dislodged the fixed ralp.The ralp embolized in the left femoral artery.The physician inserted an introducer and retrieval catheter into the patient's right femoral artery and snared the ralp.The ralp was pulled toward the introducer but met resistance in the right femoral artery.Under fluoroscopy, contrast arteriograms showed a laceration in the right femoral artery between the introducer and the ralp.Vascular surgery was initiated to retrieve the ralp and repair the vessel.The patient was stable throughout the surgery and is recovering.

• Brand Name: Aveir¿ Introducer Kit ¿ 30 cm
• Common Device Name: Introducer, Catheter
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50722109
• Report Number: 2017865-2026-19229
• Device Sequence Number: 12977342
• Product Code: DYB
• UDI-Device Identifier: 05415067034823
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K211989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: LSN25301
• Device Lot Number: 10290087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LSCD201; LSP202V
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female