CROWN PRT CNA27Recalls & reported problems
Corcym Canada Corp · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00896208000542), received between May 3, 2018 and Jun 28, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Endocarditis2
- Abscess1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2016 A MITROFLOW VALSALVA CONDUIT MVC032 AND CROWN CNA27 VALVE WAS IMPLANTED AS PART OF THE SURE-AVR TRIAL. ON (B)(6) 2017 A SERIOUS ADVERSE EVENT OCCURRED. THE PATIENT HAD ENDOCARDITIS. THIS WAS REPORTED AS THE PRIMARY ONSET AND THE MICROORGANISM IS UNKNOWN.
Patient problems: Endocarditis
MAUDE report 7648957 ↗InjuryMay 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2018 A CROWN CNA27 AORTIC HEART VALVE PROSTHESIS WAS IMPLANTED. ON (B)(6) 2018 THE VALVE WAS EXPLANTED DUE TO PROSTHETIC ENDOCARDITIS AND ABSCESS. THE VALVE WAS REPLACED WITH ANOTHER CROWN CNA27.
Patient problems: Abscess; Endocarditis
MAUDE report 7484374 ↗
Other heart-valve, non-allograft tissue devices
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- PERCEVAL PVS23Corcym Canada Corp · heart-valve, non-allograft tissue26 deaths337 reports
- MOSAIC® 305C23Medtronic, Inc. · heart-valve, non-allograft tissue327 reports
- MOSAIC® 305C25Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths324 reports
- FREESTYLE® FR995-27Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths318 reports
- FREESTYLE® FR995-29Medtronic, Inc. · heart-valve, non-allograft tissue288 reports
- FREESTYLE® FR99525Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths280 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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