MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995-23

Device Problems Material Discolored (1170); Hole In Material (1293); Device Operational Issue (2914)

Patient Problems Hemostasis (1895); Cusp Tear (2656)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this bioprosthetic valve, the physician felt the device was darker than no rmal.Further the tissue felt very rough on the coronaries when the anastomoses were done.When the heart was restarted, bleeding was noted on the non-coronary side above the green suture line.The decision was made to explant and replace the valve with a new valve of the same model.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was in the original container jar with the valve inside the sterile pouch.No solution was present.A tissue tear was noted under the sewing cloth (inner lumen) at the inferior coaptive area between the right and non-coronary cusps.The leaflets flexed with no issues observed.The device was visually inspected per the manufacturing procedures and confirmed the leaflets and tissue conditions (color and texture) were deemed acceptable.It was concluded the tear at the inflow would have been detected during manufacturing inspections and was caused by the user during the procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was received in the original container with the valve inside the sterile pouch.No solution was present.Blue monofilament sutures were observed around one of the anastomosis made adjacent to the right sinus during the procedure.There were no issues noted with the suture line and tack stitches.An 8 mm tear was noted under the sewing cloth (inner lumen) at the inferior coaptive area under the commissure marker between the right and non-coronary cusps.Visual inspection revealed the leaflets and tissue conditions were (color and texture) deemed acceptable by manufacturing quality per the manufacturing procedures.The leaflets flexed normally.The tear at the inflow would have been detected during manufacturing inspections and therefore was likely user induced.The suture line was removed, and the edge of the cloth was unfolded.Tissue was observed in place under the cloth above the suture line.There were no tears observed on the tissue behind the sewing cloth.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7142352
• MDR Text Key: 95623802
• Report Number: 2025587-2017-02544
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2021
• Device Model Number: FR995-23
• Device Catalogue Number: FR995-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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): Required Intervention