MAUDE Adverse Event Report: COOK MEDICAL LUNDERQUIST STIFF WIRE; WIRE, GUIDE, CATHETER

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Type  Death  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the lunderquist stiff guidwire was placed into the left ventricle.The patient became hypotensive and cardiopulmonary resuscitation (cpr) was performed for 20 minutes and a descending aortic rupture occurred.The cause of injury was reportedly due to cpr and possibly the guidewire.Surgical bailout was not an option, and subsequently the patient expired.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LUNDERQUIST STIFF WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 17528561
• MDR Text Key: 321039788
• Report Number: MW5135491
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1