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

Model Number PVF-L

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  Injury  

Event Description

The manufacturer was informed of this event through the device tracking department.Based on the information reported in the patient implant form, a perceval plus pvf-l was implanted, explanted and wasted on (b)(6) 2021.The patient ultimately received another perceval plus of the same size (pvf-l).No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model pvf-l , s/n # (b)(6) as they pertain to the reported event, were retrieved and reviewed by quality engineering at corcym canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model pvf-l) perceval plus heart valve at the time of manufacture and release.Since the device was reportedly discarded, no further investigation is possible at this time.Based on the information available, the root cause of the intraoperative failure to implant can be traced to a device malpositioning (use error).Per the document review performed, no device deficiencies were identified.

Event Description

The manufacturer was informed of this event through the device tracking department.Based on the information reported in the patient implant form, a perceval plus pvf-l was implanted, explanted and wasted on (b)(6) 2021.The patient ultimately received another perceval plus of the same size (pvf-l).No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.The manufacturer received additional information from the physician who confirmed that the patient did very well after the surgery.The patient was discharged home well on day 6 and had an uneventful postoperative course.Based on the medical judgment received, the patient had a very challenging narrow and funnel-shaped aortic root and difficult to expose annulus.Despite utmost precaution and due diligence, the perceval valve was implanted too low on the non-coronary aspect and was not in an optimal position when the patient was weaned from bypass, since it was impinging on the mitral valve.A decision was made to reclamp, readminister cardioplegia and explant the valve.A new perceval valve was used, which subsequently worked well.The remainder of the surgery proceeded uneventfully.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12009295
• MDR Text Key: 256532508
• Report Number: 1718850-2021-01111
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVFL(17)220816
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2022
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR