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.
Additional Manufacturer Narrative
Device remains implanted.
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.Further investigation is ongoing.
Additional Manufacturer Narrative
Based on the information available, it is not possible to draw a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified with the perceval valve involved in the event.Thrombocytopenia (tcp) in cardiac surgery is a very well-known phenomenon.The etiology is multi-factorial due to multiple factors including hemodilution, blood loss with volume repletion with platelet-poor fluids, platelet activation, consumption and destruction due to contact with foreign surfaces.Tcp following aortic valve replacement (avr) is also a common phenomenon.Patient factors and prolonged extracorporeal circulation all being recognized predictors of tcp following cardiac surgery.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity as applicable.
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.Per additional information received, there was no major impact to patient¿s recovery despite of low platelets count during post surgery recovery period.The patient was already discharged.Furthermore, there was no malfunction of the perceval valve during implantation.Tcp condition was detected on day 6th, 7th and 8th during icu recovery period.The patient was treated with transfusion.The patient was not submitted to a test to exclude hit (heparin induced thrombocytopenia).No hematological disorders were reportedly present before or during the hospital stay.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13030538
• Report Number: 3005687633-2021-00167
• Device Sequence Number: 4332016
• Product Code: LWR
• UDI-Device Identifier: 08022057014719
• UDI-Public: (01)08022057014719(240)ICV1210(17)230527
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 01/21/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/18/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male