MAUDE Adverse Event Report: MEDTRONIC, INC. FREESTYLE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FREESTYLE 995

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

Event Type  malfunction  

Event Description

Elective cab/aortic root.A 27 mm medtronic freestyle 995 bioprosthesis valve was opened.Valve sn tag was removed / standard practice and rinsed according to instructions.Dr.Received valve and prior to implantation, noted the suture that was used to attach the sn tag was embedded within the sewing ring of the valve ¿ this is a manufacturer defect.Surgeon was unable to use the valve.Valve removed from the field and sent to risk management.A new 27 mm medtronic freestyle was opened, rinsed and implanted.There was an approx.6-8 minute surgical delay to obtain, open and rinse the new valve.E-mail sent to or supply chain to not charge the patient for the defective valve.No patient harm.

• Brand Name: FREESTYLE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 1851 east deere ave.; santa ana CA 92705
• MDR Report Key: 9244313
• MDR Text Key: 163931533
• Report Number: 9244313
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2019,09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FREESTYLE 995
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 82