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

Model Number	M7-025
Medical Device Problem Codes	Fracture (1260); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a carbomedics standard mitral m7-025 was intended for a mitral valve replacement.During the implantation, the valve was reportedly "tight" and a valve leaflet fell off during the adjustment.A new valve of the same model was immediately replaced.The procedure was successfully completed with the new m7-025 and the patient had a good outcome after surgery.No perceived issues with the device were reported before the implant.
Additional 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.The device is being returned to the manufacturer and further investigation will be performed upon receipt.
Additional Manufacturer Narrative
After decontamination, the visual inspection performed on the returned valve confirmed the absence of pre-existing manufacturing defects.The dimensional verification of the implant diameter of the returned prosthesis confirmed the compliance with the specifications for a carbomedics standard mitral #25.Based on the performed analysis, the event reported from the field cannot be explained by any pre-existing factor intrinsic in the involved device.A possible reason for the observed incomplete leaflet mobility may be reasonably associated with interference with native anatomical structures.
Event or Problem Description
On (b)(6) 2019, a carbomedics standard mitral m7-025 was intended for a mitral valve replacement.During the implantation, it was reported that one of the leaflets did not move smoothly, and reportedly 'got stuck' somehow.It was attempted to adjust it, but then the leaflet fell off during adjustment.A new valve of the same model was immediately replaced.The procedure was successfully completed with the new m7-025 and the patient had a good outcome after surgery.No perceived issues with the device were reported before the implant.
Additional Manufacturer Narrative
The device was returned to the manufacturer and it was received on 23 dec 2019.The device was received with a leaflet disassembled and broken.Further investigation is ongoing and the results will be submitted upon completion.

• 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, vercelli
• MDR Report Key: 9392075
• Report Number: 3005687633-2019-00265
• Device Sequence Number: 13574231
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)230224
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2020

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: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: M7-025
• Device Catalogue Number: M7-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/06/2019; 12/23/2019; 01/19/2020
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 12/31/2019; 01/18/2020; 01/30/2020
• 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