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

Model Number 310CJ

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problems Aortic Regurgitation (1716); Congestive Heart Failure (1783); Mitral Regurgitation (1964)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis results pending.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 2 years 3 months post implant of this mitral bioprosthetic valve, the patient presented with trivial mitral regurgitation.The patient was asymptomatic.Two years ten months post implant, it was found that bnp (brain natriuretic peptide) had increased to 500 pg/ml, apparently due to the effect of an arrhythmia.Two years eleven months post implant, the patient developed acute lower back pain that led to melena.The patient received examinations at various departments other than cardiac or cardiovascular departments, but no abnormal results were obtained.A few days later, the patient was examined at the cardiovascular department.As a result, heart failure was identified and the patient was immediately admitted to the hospital.Three years post implant, a the device was explanted and replaced due to a root dislodgement.The valve's leaflet separated from the root of the device.The patient could hear an audible noise being made by the leaflet.There was no thrombus or calcification observed on the leaflet.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, remnants of green multifilament sutures remained attached to the sewing ring.The sewing ring was damaged likely during explant on the inflow tract.The stent posts appeared deflected.The left and non-coronary cusps appeared to be in the closed position.The right cusp appeared to be in the open position.All leaflets were slightly stiff but flexible except where host tissue extends on the inflow and/or outflow of the left and right cusps.The left cusp and non coronary cusp appeared intact.A large tear was observed along the margin of attachment of the right cusp which appeared to be associated with restricted leaflet movement due to possible pannus overgrowth.The tear may have increased in size during explant.Removal of pannus on the inflow may have contributed to the increase in size of the tear.The right noncoronary and left right commissures appeared intact.Condition of the left noncoronary commissure cannot be determined due to the pannus overgrowth.Glistening off white pannus lined the sewing ring on the inflow adjacent to all cusps.A thin layer of pannus extended to the tissue and base stitching, along the inflow margin of attachment, into all inferior coaptive areas, and 1 to 3 mm onto all cusps showing possible restricted leaflet movement.Removal of pannus on the inflow may have contributed to the increase in size of the tear observed on the right cusp along its base stitching.Pannus on the outflow lined the sewing ring, to the outflow rail adjacent to all cusps, extending to all stent posts, encapsulating the left noncoronary stent post and commissure, slightly restricting leaflet movement.Pannus on the outflow rail adjacent to the left cusp appeared to extend to the outflow margin of attachment.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography showed no evidence of calcification on the valve leaflets.Radiography revealed calcification embedded within the pannus along the sewing ring.Conclusion: the product analysis results show a large tear was observed along the margin of attachment of the right cusp which appeared to be associated with restricted leaflet movement due to possible pannus overgrowth.The tear may have increased in size due to removal of pannus on the inflow during explant.The pannus overgrowth on the inflow appeared to have extended several millimeters out onto the leaflet which would have significantly impaired the leaflet mobility.The impairment of leaflet mobility may have led to the regurgitation.In addition, radiography revealed calcification embedded within the pannus along the sewing ring.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 pannus overgrowth could have potentially caused the cuspal tear / immobile leaflet which led to regurgitation.Pannus overgrowth is associated with surgical valve replacement due to patient interaction and/or healing response with the surgical valve.Pannus overgrowth has been an inherent risk of surgical valve replacement.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: 6755572
• MDR Text Key: 81462190
• Report Number: 2025587-2017-01266
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980043
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2018
• Device Model Number: 310CJ
• Device Catalogue Number: 310CJ25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2013
• 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
• Patient Age: 83 YR