MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

Device Problem Difficult to Open or Close (2921)

Patient Problems Corneal Pannus (1447); Mitral Insufficiency (1963)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.

Event Description

On (b)(6) 2005 a patient received a carbomedics standard m7-031 mitral valve as part of an mvr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and an abbott epic vale was implanted as a replacement.A concomitant tricuspid valvuloplasty was performed.Additional information was received from the site on mar.16, 2020 identifying the following.The abbott valve was a size 29mm.Patient is still in the general ward but vale functionality of replacement is good.The reason for explant was the opening motion of one leaflet was not good.There was no problem at the implantation and extraction of the carbomedics valve.No imaging and no further information is available.

Manufacturer Narrative

A gross and visual inspection was performed on the returned device.The returned valve was received in an explant kit, inserted in a plastic jar of a competitor tissue valve (reasonably that one implanted instead of the returned valve presence of pannus is visible in both side of the prosthesis and, despite its presence, the leaflets opening was normal.Fibrous pannus depositions and reddish areas, due to coagulated blood entrapment, were present on both sides of the sewing ring.Small thrombus depositions were present on the inflow side of the sewing ring.In the outflow side of the sewing ring the fibrous pannus slightly protrudes in the lumen.Some calcifications were present inside the fibrous pannus that covers the outflow side of the sewing ring.The valve was then sent to the external laboratory (life & device s.R.L.Of the university of turin) with the results extracted from their histo-morphological report.Histological analyses were performed on four samples (a ¿ b ¿ c).The sample a was sampled from a portion of the inflow side of sewing ring covered by fibrous pannus depositions.Calcification, calcium debris and inflammatory cells (neutrophils and lymphocytes) were present inside the fibrous pannus deposition that covers the inflow side of sewing ring.The sample b was sampled from a portion of the outflow side of sewing ring covered by fibrous pannus depositions in relation to the calcification.Calcifications and calcium debris were present inside the fibrous pannus deposition that covers the outflow side of sewing ring.The sample c was sampled from a portion of the outflow side of sewing ring covered by fibrous pannus depositions in relation to the calcification.Calcifications and calcium debris were present inside the fibrous pannus deposition that covers the outflow side of sewing ring.Bacteria were not detected inside all sample.Once returned from the external laboratory, the functional subassemby of the valve (cphv pyrolite subassembly) was removed from the sewing cuff and thoroughly cleaned and inspected.The visual assessment on the subassembly, did not highlight any anomalies.The hydrodynamic testing conducted on the cphv subassembly #29 of the valve m7-031 ¿ sn (b)(4) was performed using the r0706 - vivitro pulse duplicator equipment.The valve showed a correct movement of the leaflets during opening and closure phases.No anomalies were observed both in normotensive and in hypotensive conditions.The reason of the reported leaflet mobility dysfunction can be reasonably attributed to the presence of pannus on the outflow side of the sewing cuff, around the lumen of the orifice, which would have compromised the correct closing and/or opening movement.Based on the performed analysis, the reported issue is not related to the device quality.Based on the performed analysis the investigation conclusion is thus deemed to be no device problem detected, and the root cause can be attributed to pannus formation.Fields changed: b4, g4, g7, h2, h6.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9851235
• MDR Text Key: 184316403
• Report Number: 3005687633-2020-00107
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: M7-031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR