MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SUTURE, NONABSORABLE, SYNTHETIC, POLYPROPYLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Device Problems Loose or Intermittent Connection (1371); Perivalvular Leak (1457)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Medtronic received information that 2 weeks following the implant of a bioprosthetic valve, transesophageal echocardiography revealed significant paravalvular leak.It was reported that the valve was functioning properly but the lsi solutions, inc.Cor-knot suturing device that was used to secure the valve to the annulus failed to keep the valve seated.The valve was explanted and replaced with a porcine valve.The patient experienced complications that are currently unknown.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SUTURE, NONABSORABLE, SYNTHETIC, POLYPROPYLENE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 17526035
• MDR Text Key: 321051361
• Report Number: MW5132975
• Device Sequence Number: 1
• Product Code: GAW
• 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: 09/26/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1