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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Endocarditis (1834)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not received.
Event or Problem Description
On (b)(6) 2017 a carbomedics m7-031 mechanical heart valve was implanted.On (b)(6) 2018 the valve was explanted and a second carbomedics m7031 mechanical heart valve was implanted.The physician explained that the device was explanted for endocarditis and abscess.There was no valve dysfunction.The patient has recovered well.
Additional Manufacturer Narrative
The manufacturing and material records for the carbomedics standard mitral valve, model #m7-031, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed.The results confirmed that this valve satisfied all material, visual, and performance standards required at the time of manufacture and release.The device history record review performed showed normal valve functionality at the time of manufacture and release.In addition, the physician analysis at the time of explant noted no valve dysfunction.Based on this the root cause can be attributed to patient condition and is deemed to be not valve related.

• 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: 7307756
• Report Number: 3005687633-2018-00120
• Device Sequence Number: 19168037
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: (01)08022057012746(240)M7-031(17)AA01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/10/2018

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: 04/01/2021
• Device Model Number: CPHV
• Device Catalogue Number: M7-031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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
• Patient Age: 46 YR