FDA Adverse Event Death Summary report: N

PERCEVAL SUTURELESS AORTIC HEART VALVE

MDR report key: 12411057 · Received September 1, 2021

Report

Report Number
1718850-2021-01163
Event Type
Death
Date Received
September 1, 2021
Report Date
August 2, 2021
Manufacturer
CORCYM CANADA CORP.
Product Code
LWR
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
SP
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

HOLD FOR GN 9-2 CUQ NOTE: THIS CASE REFERS TO PT # 11 OF 14 : (B)(6). DEAR ALL, I APOLOGIZE I AM NOT ABLE TO ACCESS ETQ, YET. THUS, I ATTACH A PAPER REPORTING 14 CASES OF ENDOCARDITIS OCCURRED IN PERCEVAL PATIENTS. (B)(6). ENDOCARDITIS ON A PERCEVAL S SUTURELESS PROSTHESIS. A NEW VALVE WITH A NEW FORM OF CLINICAL PRESENTATION. (B)(6). TIME SINCE SURGERY: 7 MONTHS. MICROBIOLOGY: CNS. TEE: IC - MITRO-AORTIC THICKENING. VEGETATION: NO. LEAK: NO. EUROSCORE I/II: 48.4% / 15.4%. PET/CT ANNULAR INVOLVEMENT/ABSCESS: + ABSCESS. SURGICAL TREATMENT: YES. SURGICAL TECHNIQUE: PATCH - PERCEVAL 23. OUTCOME: 20 MONTHS. CUQ NOTE: DEATH OCCURRED AT 7 + 20 = 27 MONTHS (?). ABBREVIATION MEANING: AVR, AORTIC VALVE REPLACEMENT; CKD,CHRONIC KIDNEY DISEASE; CNS,COAGULASE-NEGATIVE STAPHYLOCOCCUS; COPD,CHRONIC OBSTRUCTIVE PULMONARY DISEASE; IC,INCONCLUSIVE; NA, NOT APPLICABLE (PATIENT NOT SUITABLE FOR SURGERY); PET/CT POSITRON-EMISSION TOMOGRAPHY/COMPUTED TOMOGRAPHY; SI,SURGICAL INTERVENTION; TEE,TRANSESOPHAGEAL ECHOCARDIOGRAPHY; VGS,VIRIDANS GROUP STREPTOCOCCUS. THE DATA ARE EXPRESSED AS NO.(%) OR MEAN +/- STANDARD DEVIATION. SUMMARY: BASED ON INFORMATION RECEIVED FROM THE PAPER "ENDOCARDITIS ON A PERCEVAL S SUTURELESS PROSTHESIS. A NEW VALVE WITH A NEW FORM OF CLINICAL PRESENTATION" BY M.V. GROBA-MARCO. THE PATIENT WAS SUFFERING FROM PROSTHETIC VALVULAR ENDOCARDITIS (PVE). A PERCEVAL PVS 23MM WAS IMPLANTED. AFTER 3 MONTHS OF IMPLANTATION AN ECHO WAS PERFORMED WHICH SHOWED AORTIC THICKENING AND AN ABSCESS. THE PATIENT UNDERWENT SURGICAL TREATMENT AND A PERCEVAL 23MM PATCH WAS IMPLANTED. 20 MONTHS LATER THE PATIENT DIED.THIS CASE REFERS TO PT # 11 OF 14 : BASED ON INFORMATION RECEIVED FROM THE PAPER "ENDOCARDITIS ON A PERCEVAL S SUTURELESS PROSTHESIS. A NEW VALVE WITH A NEW FORM OF CLINICAL PRESENTATION" BY M.V. GROBA-MARCO. THE PATIENT WAS SUFFERING FROM PROSTHETIC VALVULAR ENDOCARDITIS (PVE). A PERCEVAL PVS 23MM WAS IMPLANTED. AFTER 7 MONTHS OF IMPLANTATION AN ECHO WAS PERFORMED WHICH SHOWED AORTIC THICKENING AND AN ABSCESS. THE PATIENT UNDERWENT SURGICAL TREATMENT AND A NEW PERCEVAL VALVE 23MM AND A PATCH WERE IMPLANTED. 20 MONTHS LATER THE PATIENT DIED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1305426 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM CANADA CORP. PVS23

Patients

Seq Age Sex Outcome Treatment
1 79 YR Death| R