MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVS25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombocytopenia (4431)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a perceval valve pvs25 was implanted in a patient.The patient is recently diagnosed with pneumonia and started on antibiotic.The post-opt recovery was prolonged (still in icu due to thrombocytopenia).The patient has been under observation since 1 day postop until (b)(6) 2021.It is presently unknown if the patient recovered or is still under treatment.The patient¿s pre-operational assessment has no other comorbid condition beside the old age.The patient was tested with a support of a hematologist and the result tested nothing related to patient's platelet.The perceval valve was suspected as a possible contributing factor to thrombocytopenia.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 13030408
• Report Number: 3019892983-2021-01053
• Device Sequence Number: 4452661
• Product Code: LWR
• UDI-Device Identifier: 08022057014719
• UDI-Public: (01)08022057014719(240)ICV1210(17)230527
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2021
• Report Date (Section F): 11/18/2021

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: 05/27/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2021
• 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: Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Male