MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 310C

Device Problems Material Rupture (1546); Incomplete Coaptation (2507); Material Distortion (2977)

Patient Problem Mitral Regurgitation (1964)

Event Date 07/23/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis in progress.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that when this bioprosthetic valve was removed from its packaging, the cinch mechanism was loose.The physician decided to attempt to implant the device anyways.After suturing the device into place, hydrostatic tests indicated that valve did not coapt properly which caused central regurgitation.The physician checked to be sure that the sutures were not poorly placed and that there was no retracting muscle.Additionally, the physician reported that one of the valve leaflets was thickened.A decision was made to explant the device during the procedure.During explant, two leaflets of the valve ripped.A non-medtronic device was implanted.No additional adverse patient effects were reported. .

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the holder was returned with the valve detached.Visual examination of the valve showed evidence of blood contact.Suture holes and damage (cut) was observed on the sewing ring.The valve was distorted; oval shaped, with the stent posts deflected.All leaflets were in open position.All leaflets were slightly stiff but flexible.The left cusp and non-coronary cusp exhibited tears.Other than the tears noted, the tissue characteristic was found acceptable.Due to the receipt condition of the explanted device, functional testing regarding the coaptation could not be performed and a conclusive cause of the regurgitation could not be determined.The valve holder was open and intact.There was no evidence of damage on the valve holder and/or rotor.Under magnification, the tips of the sutures were observed.The suture tips were jagged not smooth, indicating they were broken or torn rather than cut.The break surface of each tip is consistent with historical events that indicate a tension break.Necking or reduction in diameter was noted adjacent to the breaks.The rotor was removed from the valve holder intact.In order to determine whether the cinch holder was activated prior to breakage of the suture, the white rotor was removed from the blue holder.It was observed that suture was wound around the rotor.During the ratcheting process, as the rotor is turned in a clockwise direction, tension is applied on the ratcheting suture which results in the suture getting pulled into the legs of the holder to deflect the stent posts.This pull results in the suture winding around the rotor.The likely cause of the event is due to the customer over-ratcheting the cinch mechanism.Per mosaic ifu, it cautions ¿the suture used to deflect the stent posts may break if the handle is over tightened.¿ 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.The analysis indicated that the valve was distorted.The distortion of the annular ring can potentially restrict the leaflets from fully opening and/or cause misalignment of leaflets during valve closure which may have led to regurgitation.Exactly when and how the distortion occurred cannot be determined; however, per medtronic¿s inspection procedure, each mosaic valve is inspected for distortion and this valve passed the inspection prior to release for distribution.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• 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: 6863180
• MDR Text Key: 86070380
• Report Number: 2025587-2017-01607
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P990064
• 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
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 310C
• Device Catalogue Number: 310C25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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
• Patient Age: 60 YR
• Patient Weight: 68