MAUDE Adverse Event Report: ST. JUDE MEDICAL TEMPORARY PACING LEAD

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

Patient Problems Fistula (1862); Pseudoaneurysm (2605); Vascular Dissection (3160)

Event Type  Injury  

Event Description

The following was published in anatolian journal of cardiology, suppl.Supplement 1 26 : s95-s96.Turkish society of cardiology.(dec 2022) "comparison of left ventricular guidewire pacing versus right ventricular rapid pacing among patients undergoing tavi with portico valve", dr.Yildirim, abdullah.A total of 147 patients with symptomatic severe aortic stenosis who underwent transcatheter aortic valve implantation (tavi) with a portico valve were included in the study, retrospectively.In the conventional group, balloon-tipped temporary pacing catheters (5-f pacel, abbott) were inserted in rv after 6 fr sheaths were put by femoral access.In the lv pacing group, 0.035- inch innowi (symedrix gmbh) was utilized in conjunction with the transcatheter valve delivery system.Using a clip, one of the electrodes was linked to the wire at one end and the pacing generator at the other.The other electrode was attached to a short wire that was either inserted in a sheath or applied to the skin with a local anesthetic.Both groups experienced similar procedural complications.The lv pacing group had fewer peripheral complications.30-day outcomes such as all-cause mortality, cardiovascular mortality, bleeding, stroke, acute kidney injury, and the requirement for a permanent pacemaker were likewise comparable.Conclusions: the following are the key findings of the current study; (i) there was no significant difference in 30-day clinical outcomes between the two pacing groups, (ii) procedural times and the opaque amount may be less in the lv pacing group because it does not require additional venous vascular or right ventricular access, is quickly applicable, and is simple to use, (iii) as a consequence, lv pacing with the portico valve appears to be as reliable, safe, simple, and effective as traditional rv pacing.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported pseudoaneurysm, dissection, af fistula and vascular complications remain unknown.

• Brand Name: TEMPORARY PACING LEAD
• Type of Device: TEMPORARY PACING LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16329498
• MDR Text Key: 309122625
• Report Number: 2182269-2023-00007
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K152784
• 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,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other