MAUDE Adverse Event Report: CORCYM CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number TBD

Device Problems Calcified (1077); Degraded (1153)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 05/17/2019

Event Type  Death  

Event Description

The manufacturer received the following information through a publication issued on a japanese academic medical journal (the 123rd annual congress of japan surgical society).The paper was presented as a poster at the 123rd annual congress of japan surgical society (jssoc.Or.Jp), author shintaro takago.The scope of the published study was to analyze the data related to 56 crown prt cases performed from january 2016 to december 2019.The average post operative observation duration was 40.3+-22.1 months.It was reported that 26 out of 27 patients died due to non valve related disease, such as cancer, but there was one case due to heart failure which was related to severe svd.

Manufacturer Narrative

The manufacturer is following up with the author of the publication to identify the involved device and retrieve additional information on the event.A follow up report will be submitted upon receival of additional information.H3 other text : unknown disposition.

Manufacturer Narrative

Since it was not possible to retrieve the device sn and the valve was not returned to the manufacturer for analysis, the manufacturer couldn't perform any direct investigation on the prosthesis involved in the reported event, nor review the related production records.Based on the information received, it should be considered though that patient had already experienced acute heart failure at the time of surgery and presented several risk factors, specifically hypertension, chronic obstructive pulmonary disease and tobacco use as well as coronary artery disease treated with cabg at the time of crown valve implant.As reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this crown valve.Another factor that can play a role in svd, according to scientific literature, is related to valve size.In fact, prosthesis-patient mismatch has also been found to accelerate the development of svd, due to an increased transvalvular gradient and excessive mechanical stress.Due to the paucity of available information, it has not been possible to evaluate this aspect as a possible contributing factor in this specific case.Ultimately, it should be noted that structural valve deterioration is listed as a possible adverse event in the device ifu.The event is, therefore, a known inherent risk of the device.

Event Description

The manufacturer received the following information through a publication issued on a japanese academic medical journal (the 123rd annual congress of japan surgical society).The paper was presented as a poster at the 123rd annual congress of japan surgical society (jssoc.Or.Jp), author shintaro takago.The scope of the published study was to analyze the data related to 56 crown prt cases performed from january 2016 to december 2019.The average post operative observation duration was 40.3+-22.1 months.It was reported that 26 out of 27 patients died due to non valve related disease, such as cancer, but there was one case due to heart failure which was related to severe svd.As per additional information received, the patient involved in this case had been implanted on (b)(6) 2016.Patient's clinical history included hypertension, chronic obstructive pulmonary disease and tobacco use.At the time of surgery the patient had recovered from acute heart failure.Medical therapy at discharge was tanatril and callock.An echocardiography performed on (b)(6) 2016 had shown trivial ar and elevated gradients, with mpg 30 mmhg.A further echo check was performed on (b)(6) 2019 with the following results: 1 degree of transvalvular regurgitation, calcification and increased flow velocity (vmax 3.8 m/s, mpg 31 mmhg, ava 1.05-1.17 cm2.).Reportedly, patient had dyspnea on exertion noted at the follow-up observation performed back on (b)(6) 2018.It was also reported that patient was hospitalized and treated for transient ischemic attack on (b)(6) 2019 (no anticoagulation with warfarin had been administered) and biazpirin was added to the medical therapy.Due to worsening of dyspnea, the patient was subsequently hospitalized on (b)(6) 2019 and ultimately passed away on (b)(6) 2019.No autopsy or analysis on the device were performed after the death.As reported, at the time of death, the patient was under imidapril, azelnidipine, azosemide, biazpirin.

• Brand Name: CROWN PRT PERICARDIAL 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 Key: 18018280
• MDR Text Key: 326673719
• Report Number: 3004478276-2023-00189
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 41 KG