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

Model Number	CPHV
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019 a patient was intended to receive a carbomedics optiform f7-025 mitral valve as part of an mvr.The manufacturer was notified that after the implantation of heart valve, when the site tried to rotate the device, they experienced difficulties and the valve didn't rotated.The site explanted the valve.No further information was received.
Additional Manufacturer Narrative
The valve was returned to livanova for evaluation and received on december 11, 2019.The valve was received in the original plastic jar in dry conditions.One valve leaflet was in the correct position and the second leaflet appeared to be blocked in unnatural position inside the orifice.The pivot of this leaflet appeared to be broken.Fragments of the broken leaflet were found inside the jar.At the incoming visual inspection, performed before and after the sanitization and cleaning, the sewing cuff appeared slightly rotated and in a general good condition, with very light traces of blood considering the reported event description stating that the valve was implanted.Further visual inspection and a simulated use were performed.The results of the investigation showed evidences of limited traces of suture stiches, suggesting an implanting procedure was not totally completed.The rotation of the valve, despite the description given, was observed on the returned device.Furthermore the attempt, made on the returned valve, did not show particular difficulties in the rotation movement.The broken leaflet was found stuck inside the orifice in a reversed position (back/front side and outflow/inflow surface) likely because the leaflet was freely moving in the jar and during the transport.The breakage of the leaflet is a typical fracture documented in the literature for the pyrolitic carbon fractures.Base don these observances it is possible a mishandling of the device occurred during implantation.An initial manipulation of the leaflet (i.E.Over-rotation) could have caused an increasing load at the ears level until reaching the ultimate strength of the leaflet and pyrolitic carbon coating (structural breakage limit) resulting leaflet breakage observed.Based on the performed analysis, the problem experienced by the customer can likely be related to mishandling and cannot be explained by any intrinsic pre-existing factor in the involved device.The conclusion code is thus cause traced to user, unintended use error caused or contributed to event.The manufacturer has also requested additional event information but has not received further details.If further event altering information is received the competent authority will be updated.
Additional Manufacturer Narrative
A gross investigation of the returned valve was performed.The valve was received in the original plastic jar in dry conditions.The valve has a leaflet still in the correct position and the second one blocked in unnatural position inside the orifice.This leaflet resulted with a pivot broken.Fragments of the broken leaflet were found inside the jar.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9484910
• Report Number: 1718850-2019-01210
• Device Sequence Number: 10827630
• Product Code: LWQ
• UDI-Device Identifier: 08022057012845
• UDI-Public: (01)08022057012845(240)F7-025(17)240516
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2020
• Report Date (Section F): 11/18/2019

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: 05/16/2024
• Device Model Number: CPHV
• Device Catalogue Number: F7-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/18/2019; 11/18/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/19/2020; 01/27/2020
• 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