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

Model Number 305U

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Mitral Regurgitation (1964)

Event Date 05/21/2015

Event Type  Injury  

Event Description

Medtronic received information that one year, six months post implant of this bioprosthetic aortic valve, implanted in the mitral position, this valve was explanted and replaced with a competitor's mechanical valve due to valvular regurgitation.No adverse patient effects were reported.

Manufacturer Narrative

Attempts to obtain additional information regarding this patient and event have been unsuccessful.A supplemental report will be submitted with the analysis and investigation results.(b)(4).

Manufacturer Narrative

Patient sex has been changed from male to female.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual inspection of the valve indicated that it was distorted (oval-shaped).All leaflets were slightly stiff but flexible.The left cusp was intact.A small puncture observed in the non-coronary cusp along the inflow margin of attachment was determined to have occurred during explant.An intracuspal hematoma was observed in the right cusp.Perforations observed in the right cusp along the margin of attachment adjacent to the left right commissure were determined to be associated with contact with the base stitching and/or a possible long suture tail.Tissue deterioration was observed in the septal shelf or muscle bar on the right cusp.All commissures were intact.Remnants of pannus were observed on the inflow along the sewing ring and tissue and base stitching adjacent to the left cusp.Traces of pannus were observed along the sewing ring on the outflow and outflow rails.Radiography showed no evidence of mineralization in the valve and/or host tissue.The investigation is ongoing; a supplemental report will be filed upon completion of the investigation.(b)(4).

Manufacturer Narrative

Conclusion: 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.In addition, histopathology of the valve showed there were no significant histologic changes to the right cusp leaflet to indicate the cause for the hemorrhage and tearing.No significant evidence of degeneration of the other cusps was present.These findings would be consistent with possible contact of the valve with suture material.Based on the received information and the returned product analysis, the reported regurgitation is most likely due to the cuspal tear and perforation.The tears / elongations in the right cusp of this explanted valve were determined to be due to repeated contact of the leaflet with the base suture line.The base stitching in this area was very close to the flexing area of the cusp, increasing the potential for contact of the leaflet with the base suture.In addition, this aortic valve was implanted in the mitral position; the back pressure from the mitral valve would have exacerbated the wear.The distortion of the annular ring can restrict the leaflets from fully opening and/or cause misalignment of leaflets during valve closure.Based on historical observations, the distortion of the annular ring (oval shape) can result in more contact of the leaflet onto the cloth due to the altered position of the outflow rail and stent posts.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC ULTRA PORCINE 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4851533
• MDR Text Key: 5935818
• Report Number: 2025587-2015-00657
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2018
• Device Model Number: 305U
• Device Catalogue Number: 305U2J21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 06/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/20/2015
• Supplement Dates FDA Received: 06/18/2015; 07/20/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2013
• 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