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

Model Number	CPHV
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device being shipped to manufacturer.
Event or Problem Description
On (b)(6) 2018 a carbomedics standard m7-033 mechanical mitral valve was implanted.During the operation a fluid test was performed and central leakage/regurgitation was observed through the valve leaflets.The valve was explanted and replaced with another carbomedics standard m7-033 mechanical valve.The failure to implant resulted in 20 minutes of addtional x-clamp time.The patient had a normal recovery.
Additional Manufacturer Narrative
A gross inspection was performed on the received device.The returned valve prosthesis was received in a dry condition, coated in blood.In the preliminary analysis, the valve prosthesis appeared with the leaflets stuck.Review of the data filed in the device history record confirmed that the component used to manufacture the returned carbomedics standard sn (b)(4) satisfied all material, dimensional, and performance standards required for a carbomedics standard m7-033 at the time of the manufacture and release.The visual inspections performed on the returned prosthesis confirmed the absence of pre-existing manufacturing defects.A hydrodynamic test was performed to test the valve flow characteristics in standard bodily flow conditions.The hydrodynamic testing conducted on the returned prosthesis confirmed that the device was showed normal leaflet kinematics and it did not reveal any anomalies during the opening/closing phases.No coaptation issues were identified.The results of the returned carbomedics standard size m7-033 s1056186-m show that the device meets the iso 5840 minimum requirements.Based on the performed analysis the reported event cannot be explained by any factor intrinsic to the device in question.At this time the root cause is thus deemed to be indeterminable as no problem was found during the investigation process.If further information is receive the manufacturer will reassess the investigation.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7478478
• Report Number: 3005687633-2018-00146
• Device Sequence Number: 19073163
• Product Code: LWQ
• UDI-Device Identifier: 08022057012753
• UDI-Public: (01)08022057012753(240)M7-033(17)220526
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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
• Operator of Device: Physician
• Device Expiration Date: 05/27/2022
• Device Model Number: CPHV
• Device Catalogue Number: M7-033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention