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

Model Number 305U2J

Device Problem Material Rupture (1546)

Patient Problems Congestive Heart Failure (1783); Hemolysis (1886)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

Additional information was requested, regarding the exact implant duration and the patient's demographic information.No further in formation was provided.Please note, the device implant date is an estimate.If additional information is received, a supplemental report will be submitted.

Event Description

Medtronic received information that approximately five years post implant of this bioprosthetic valve, this product was explanted and replaced.Upon explant, a tear was identified at the commissures between the right coronary cusp and non coronary cusp as well as between the right coronary cusp and left coronary cusp.The patient's symptoms prior to the replacement procedure include heart failure and hemolysis.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.The valve was rotated in the stent, with the right cusp of the valve to the non-coronary cusp position in the stent.Per manufacturing procedures, depending on the structure of the porcine tissue, a valve may be rotated to accommodate the appropriate fit to the stent.All leaflets were slightly stiff but flexible except where host tissue and/or mineralization extend on the inflow and/or outflow.Tissue deterioration due to mineralization was observed on all leaflets.A small tear observed on the non-coronary cusp adjacent to the right non-coronary commissure appeared to be associated with explant.The non-coronary left commissure appeared to be intact.Tissue deterioration due to mineralization was observed on the left right and right non-coronary commissures.Remnants of pannus remained attached to the tissue and base stitching adjacent to all existing cusps, extending into all inferior coaptive areas, and 1 to 3 mm onto all existing cusps showing a reduced inflow orifice area.Remnants of pannus remained attached to the existing sewing ring on the outflow, extending to the backs of all stent posts and outflow rail adjacent to the right cusp.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography showed mineralization in all leaflets and two commissures.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.Based on the received information and the returned product analysis, the observed calcification could have potentially caused the tissue deterioration / cuspal tear.Calcification has been an inherent risk of surgical valve replacement.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 approximately five years post implant of this bioprosthetic valve, this product was explanted and replaced with a competitor's valve.Upon explant, a tear was identified at the commissures between the right coronary cusp and non coronary cusp as well as between the right coronary cusp and left coronary cusp.The patient's symptoms prior to the replacement procedure include heart failure and hemolysis.No other adverse patient effects were reported.

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 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: 5788255
• MDR Text Key: 49362135
• Report Number: 2025587-2016-01029
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 10/05/2016

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: 11/09/2015
• Device Model Number: 305U2J
• Device Catalogue Number: 305U2J23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided; 10/05/2016
• Supplement Dates FDA Received: 10/10/2016; 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2010
• 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