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

Model Number PVS23

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/20/2021

Event Type  Death  

Manufacturer Narrative

Not explanted (unknown if autopsy performed).

Event Description

On (b)(6) 2016, a patient received a perceval valve pvs23.The pre-operative assessment indicated symptomatic moderate to severe aortic stenosis (mg- 39 mm hg), preserved lv function, and mild to moderate mitral regurgitation (mr).The procedure was uneventful, the intraoperative toe showed satisfactory appearance of the prosthetic valve with pg/mg 15/8 mmhg and no regurgitation.The patient was discharged on (b)(6) 2016.The patient was admitted to the hospital on 20 aug 2021 after having episodes of worsening shortness of breath.The echo showed worsening aortic regurgitation (ar), becoming severe in the last 4 months.A degeneration of the perceval valve¿s leaflets was identified, causing ar.The echo also showed mild pah (rvsp 43 mm hg) and mitral regurgitation (mr) moderate in severity.Of a note, the patient¿s mr has been variable in last few years.The patient was discharged on 31 aug 2021 with a diagnosis of decompensated heart failure secondary to severe eccentric aortic regurgitation (ar).A follow up was schedule for 4-6 week¿s time to discuss treatment options (tavi v/s surgical avr).However, the patient reportedly passed away in (b)(6) 2021.Data on the device functionality over time was provided as follows: on (b)(6) 2017, the perceval valve had a peak/mean gradient of 33/21mmhg, with no aortic regurgitation.The ejection fraction was 65%.On (b)(6) 2021, the perceval valve showed raised peak/mean gradient 36/22 mmhg.Mild to moderate aortic regurgitation (no ar noted on previous echo) suggestive of degeneration; thickened mitral valve with moderate to severe mitral regurgitation was also noted, as well as mild tricuspid degeneration.On (b)(6) 2021, the echo showed that the posterior cusp (nnc) of the perceval valve is restricted with mild aortic stenosis and mild to moderate ae.These changes were noted to be consistent with degenerative pathology.The left ventricular ejection fraction was normal.The patient¿s previous clinical history includes type-2 diabetes (on insulin), dyslipidemia, hypertension, thyroidectomy, hysterectomy, osteoarthritis, osteoporosis, sleep apnoea (not using c-pap machine), anxiety.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.Further investigation is ongoing.

Event Description

On (b)(6) 2016, a patient received a perceval valve pvs23.The pre-operative assessment indicated symptomatic moderate to severe aortic stenosis (mg- 39 mm hg), preserved lv function, and mild to moderate mitral regurgitation (mr).The procedure was uneventful, the intraoperative toe showed satisfactory appearance of the prosthetic valve with pg/mg 15/8 mmhg and no regurgitation.The patient was discharged on (b)(6) 2016.The patient was admitted to the hospital on (b)(6) 2021 after having episodes of worsening shortness of breath.The echo showed worsening aortic regurgitation (ar), becoming severe in the last 4 months.A degeneration of the perceval valve¿s leaflets was identified, causing ar.The echo also showed mild pah (rvsp 43 mm hg) and mitral regurgitation (mr) moderate in severity.Of a note, the patient¿s mr has been variable in last few years.The patient was discharged on (b)(6) 2021 with a diagnosis of decompensated heart failure secondary to severe eccentric aortic regurgitation (ar).A follow up was schedule for 4-6 week¿s time to discuss treatment options (tavi v/s surgical avr).However, the patient reportedly passed away in (b)(6)r 2021.Data on the device functionality over time was provided as follows: on (b)(6) 2017, the perceval valve had a peak/mean gradient of 33/21mmhg, with no aortic regurgitation.The ejection fraction was (b)(4).On (b)(6) 2021, the perceval valve showed raised peak/mean gradient 36/22 mmhg.Mild to moderate aortic regurgitation (no ar noted on previous echo) suggestive of degeneration; thickened mitral valve with moderate to severe mitral regurgitation was also noted, as well as mild tricuspid degeneration.On (b)(6) 2021, the echo showed that the posterior cusp (nnc) of the perceval valve is restricted with mild aortic stenosis and mild to moderate ae.These changes were noted to be consistent with degenerative pathology.The left ventricular ejection fraction was normal.The patient¿s previous clinical history includes type-2 diabetes (on insulin), dyslipidemia, hypertension, thyroidectomy, hysterectomy, osteoarthritis, osteoporosis, sleep apnoea (not using c-pap machine), anxiety.Based on the medical judgment received, the cause of death was not identified and no judgment is available on the relationship with the perceval valve implanted.The patient¿s diabetes was reportedly well managed.

Manufacturer Narrative

The manufacturer received a few more details on the event and a revised summary was provided in b5.Since the device was not returned (no evidence of autopsy being performed), no further investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.It is possible that the patient's clinical history and risk factors (i.E.Type-2 diabetes (on insulin), dyslipidemia, hypertension, thyroidectomy, hysterectomy, osteoarthritis, osteoporosis) may have contributed to the reported structural valve degeneration of this perceval valve.Ultimately, since no inspection on the prosthesis was possible, this cannot be definitively confirmed.It should be noted that structural valve deterioration is included as a possible adverse event in the perceval ifu.Thus, the event is a known inherent risk of the device.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12933308
• MDR Text Key: 281738939
• Report Number: 3004478276-2021-00286
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)181124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2018
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2015
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 80 KG