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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL LUNDERQUIST EXTRA STIFF WIRE GUIDE; WIRE, GUIDE, CATHETER
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COOK MEDICAL LUNDERQUIST EXTRA STIFF WIRE GUIDE; WIRE, GUIDE, CATHETER Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Ventricular Fibrillation (2130); Mitral Valve Insufficiency/ Regurgitation (4451)
Event Type  Death  
Event Description
Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve after obtaining bilateral femoral access and using standard exchanges, a super stiff lunderquist guidewire was inserted into the left ventricle.The patient became tachycardic and hypotensive.Aortogram verified there was no wire perforation nor trauma to the aortic root and abdominal aorta.The patient was intubated and transesophageal echocardiogram (tee) verified there was no pleural effusion and revealed severe mitral regurgitation.A coronary angiogram showed the right coronary artery was widely patent.The blood pressure began to drop and the valve was implanted at 3mm on the non-coronary cusp and 4mm on the left coronary cusp.An intra-aortic balloon pump was initiated with no effect on the blood pressure.The cardiac rhythm converted to ventricular fibrillation and the cardiopulmonary resuscitation (cpr) was performed.The patient was shocked several times and expired on the table.The family requested that no autopsy be performed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
LUNDERQUIST EXTRA STIFF WIRE GUIDE
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
COOK MEDICAL
MDR Report Key17529869
MDR Text Key321039879
Report NumberMW5136792
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
Treatment
DSP
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