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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE; TISSUE HEART VALVE

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CORCYM CANADA CORP. PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE; TISSUE HEART VALVE Back to Search Results
Model Number PVF-XL
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Atrial Fibrillation (1729); Heart Block (4444)
Event Date 02/06/2024
Event Type  Injury  
Manufacturer Narrative
H3 other text : device remains implanted.
 
Event Description
The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve size xl was implanted in the patient on (b)(6) 2024.Based on information received, patient had chb with afib on (b)(6) 2024.The patient needed a permanent pacemaker which was implanted on (b)(6) 2024 to resolve the issue.As reported, the patient's clinical history included coronary artery disease; arrhythmia: afib; systemic hypertension; diabetes mellitus: type ii, insulin dependent; dyslipidemia; renal insufficiency / renal disorder (dialysis ongoing); percutaneous coronary intervention (stenting 2019); and was in nyha class iii.Based on the information available, prior and concomitant anticoagulant/antiplatelet medications are warfarin, eliquis and aspirin.
 
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Brand Name
PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE
Type of Device
TISSUE HEART VALVE
Manufacturer (Section D)
CORCYM CANADA CORP.
5005 north fraser way
burnaby, bc V5J 5 M1
CA  V5J 5M1
Manufacturer (Section G)
CORCYM CANADA CORP.
5005 north fraser way
burnaby, bc V5J 5 M1
CA   V5J 5M1
Manufacturer Contact
laura mannino
5005 north fraser way
burnaby, bc V5J 5-M1
CA   V5J 5M1
MDR Report Key18861790
MDR Text Key337183454
Report Number3004478276-2024-00120
Device Sequence Number1
Product Code LWR
UDI-Device Identifier00896208000825
UDI-Public(01)00896208000825(240)PVF-XL(17)270421
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150011/S013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPVF-XL
Device Catalogue NumberPVF-XL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient SexMale
Patient Weight114 KG
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