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

Model Number	PVS21
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a perceval valve size s was attempted to be implanted.Based on the echo performed, annulus was measured as 19mm.Standard sizing was carried out, and small valve was deployed.Reportedly, following deployment surgeon noted pin wheeling and infolding of nitinol cage.The perceval was explanted and replaced by standard sutured valve.Based on further information received, a perimount valve size 19 was implanted instead.Surgeon believes if smaller size of perceval existed, it would have worked better in this situation.Reportedly, they did not get to the ballooning stage and patient remained stable throughout the delay in procedure.There was no impact on patient, and overall outcome was good.
Additional Manufacturer Narrative
H3 other text : disposed by site.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6.The manufacturing and material records for the perceval heart valve and stent, model # icv1208-au, 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 has been manufactured and controlled in accordance with the specifications for a model # icv1208-au perceval heart valve at the time of manufacture and release.Based on the document review, no manufacturing deficiencies were noted with the device.Based on the medical judgement available (i.E., "if smaller size of perceval existed, it would have worked better in this situation").As such, the possible cause of the reported event can be related to oversizing.Furthermore, it was reported that ballooning was not performed.It should be noted that a post-dilation of the inflow ring is to be carried out after the total deployment of the prosthesis, as indicated in ifu.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: 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: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18097218
• Report Number: 3004478276-2023-00194
• Device Sequence Number: 14853449
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)240909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2024
• Device Model Number: PVS21
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female