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

Model Number 305U

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis in process.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 during the implant of this bioprosthetic valve, a leaflet tear was discovered after tying down the sutures.The device was explanted and replaced with new valve of the same model.It is unknown if the leaflet tear occurred during implant or if the leaflet tear was already there before unpacking the valve.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve showed evidence of blood contact.White multifilament suture was found attached to the sewing cloth adjacent to the left cusp.A cut was observed through the sewing cloth adjacent to the left cusp, which appeared to be from a sharp object.The damage to the cloth extended up to the outflow rail.All leaflets were in open position.All leaflets were slightly stiff but flexible.All commissures were intact.Tears on the left cusp lunula were observed.A tear along the belly of the non-coronary cusp was observed.The device was visually inspected by manufacturing quality.Per the manufacturing engineers, the type of damage found on the left cusp and non-coronary cusp can be detected during manufacturing.Conclusion: the device history record was also reviewed and shows that this valve met all manufacturing specifications for product released to distribution.Exactly what caused (when and how) the tissue damage cannot be determined; however during 100% inspection of the final assembly at medtronic, the tissue was not damaged.Based on the received information and analysis results of the returned device, the clinical observations, tear, was confirmed.The cause of the tear was probably related to the accidental damage during preparation / implant with a sharp instrument.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC 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: 6905772
• MDR Text Key: 87841535
• Report Number: 2025587-2017-01726
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: 305U
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2017
• 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: 76 YR