MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AVEIR¿ INTRODUCER KIT ¿ 50 CM; INTRODUCER, CATHETER

Model Number	LSN25501
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for an initial implant of a right ventricular aveir leadless pacemaker (rvlp) on (b)(6) 2025.During the implant, there was difficulty inserting the introducer sheath over the wire through the right iliac vein (ivc-ra) and it was noted that the sheath was kinked.After maneuvering the introducer, the physician was able to advance the introducer up to the ivc-ra junction.Contrast shots were taken upon introducing the rvlp and delivery catheter (dc) into the right ventricle and it was decided to pull them back and re-advance.Post re-advancing the rvlp and dc, the patient experienced low blood pressure and supraventricular tachycardia (svt).An ultrasound was performed and no cardiac perforation was noted.The svt was successfully converted twice using cardioversion.Hypotension continued and was treated via cardiopulmonary resuscitation (cpr).The patient experienced a broken rib from the cpr.A medical emergency response team (mert) was called, and they performed a blood gas test which suggested there was a venous bleed.The physician elected to remove the rvlp and dc and close the wound.Ivc bleed was ruled out via venogram, and more distal access was achieved and another venogram performed which confirmed right iliac dissection.The patient received an urgent stent to the right iliac vein.The patient was in stable condition.
Additional Manufacturer Narrative
A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities and passed all quality control tests prior to its distribution.
Additional Manufacturer Narrative
H2 in follow up number 1 should have "additional information" selected".

• Brand Name: AVEIR¿ INTRODUCER KIT ¿ 50 CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23418657
• Report Number: 2017865-2025-1003690
• Device Sequence Number: 8946064
• Product Code: DYB
• UDI-Device Identifier: 05415067034847
• UDI-Public: (01)05415067034847(10)10814486(17)260331
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: LSN25501
• Device Lot Number: 10814486
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 01/05/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/30/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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: Required Intervention
• Patient Sex: Unknown