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

Model Number PVS21

Device Problems Leak/Splash (1354); Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

Although the regurgitation was attributed to the presence of calcifications that seems to push the stent (patient's factors) the event is being notified due to unknown impact on patient for intraoperative explant.Furthermore, from the information reported, it appears that the perceval valve was re-implanted after the intraoperative explant.Per the perceval valve ifu ''a removed perceval s prosthesis must not be reimplanted, because its integrity is no longer ensured.''.Thus, the decision to re-implant the same prosthesis was made off-label.The manufacturer is performing further investigation and will update this reporting activity based on additional information received.Device was infected, not available for return.

Event Description

The patient underwent a re-do avr procedure on (b)(6) 2021, where a crown cna19 was explanted (submitted separately under livanova ref 2021-02832) and a perceval valve pvs21 was implanted.A midline incision was performed to remove the crown valve and surrounding atheroma (plaque) and myxoma.The circumference of the annulus was trimmed and sized to select the perceval valve.After the implant, the echocardiogram showed regurgitation around the valve from the rcc (mild> trivial) and from ncc (trivial), so the cross clamp was restarted.The implant position of perceval valve appeared acceptable, but the calcification adhering to the vicinity of the annulus from the left coronary artery seemed to push the stent, so the device was re-implanted was repeated again.Before re-implanting the valve, decalcification was performed again and the size was confirmed.At the time of confirmation by the subsequent echo, the regurgitation around the valve was small, but the trivial regurgitation was confirmed on the rcc side.Since there was little reflux, weaning was attempted, but cardiac function did not improve and iabp was placed.Echo confirmation after the start of iabp showed that rcc regurgitation increased from trivial to mild.The regurgitation remained from the part where the hardness of the annulus was different but it could not be confirmed the reason why the regurgitation remained.Since it was expected that iabp would be used in combination after withdrawal from extracorporeal circulation, perceval valve was removed and a mosaic valve 19 mm was implanted instead during the same day (b)(6) 2021.The additional extracorporeal circulation time: 2 hours 12 minutes.The additional cross clamp time: 1 hour 28 minutes.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # a98180, 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 #icv1208) perceval heart valve at the time of manufacture and release.Since the valve will not be returned no more investigation can be performed.Based on the available information, it is not possible to draw a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Based on the information available the regurgitation was attributed to the presence of calcifications that seems to push the stent (patient's factors) the event is being notified due to unknown impact on patient for intraoperative explant.Furthermore, from the information reported, it appears that the perceval valve was re-implanted after the intraoperative explant.Per the perceval valve ifu ''a removed perceval s prosthesis must not be reimplanted, because its integrity is no longer ensured.''.Thus, the decision to re-implant the same prosthesis was made off-label.

Manufacturer Narrative

Since the device was not returned (reportedly due to infection), no further investigation could be performed.Based on the available information, it is not possible to establish a definitive root cause for the reported event of perivalvular leak.However, from the document review performed, no manufacturing deficits were identified in the perceval valve pvs21.As reported, after the first implant attempt, "the implant position of perceval valve appeared acceptable, but the calcification adhering to the vicinity of the annulus from the left coronary artery seemed to push the stent".Furthermore, in the second attempt, "the peri-valvular regurgitation remained from the part where the hardness of the annulus was different".As such, it is possible that an incomplete decalcification or other patient's specific factors could have contributed to reported event.However, since no further information was provided and no device investigation was possible, this cannot be ultimately confirmed.It should be noted that the perceval valve ifu contains the following warning: "a removed perceval s prosthesis must not be reimplanted, because its integrity is no longer ensured".As such, the decision to re-implant the same prosthesis was made off-label.

Event Description

The patient underwent a re-do avr procedure on(b)(6) 2021, where a crown cna19 was explanted (ref (b)(4).) and a perceval valve pvs21 was implanted.A midline incision was performed to remove the crown valve and surrounding atheroma (plaque) and myxoma.The circumference of the annulus was trimmed and sized to select the perceval valve.After the implant, the echocardiogram showed regurgitation around the valve (i.E.Perivalvular leak) from the rcc (mild> trivial) and from ncc (trivial), so the cross clamp was restarted.The implant position of perceval valve appeared acceptable, but the calcification adhering to the vicinity of the annulus from the left coronary artery seemed to push the stent, so the same device was re-implanted.Before re-implanting the valve, decalcification was performed again and the size was confirmed.At the time of confirmation by the subsequent echo, the regurgitation around the valve was small, but the trivial regurgitation was confirmed on the rcc side.Since there was little reflux, weaning was attempted, but cardiac function did not improve and iabp was placed.Echo confirmation after the start of iabp showed that rcc regurgitation increased from trivial to mild.The peri-valvular regurgitation remained from the part where the hardness of the annulus was different but it could not be confirmed the reason why the regurgitation remained.Since it was expected that iabp would be used in combination after withdrawal from extracorporeal circulation, perceval valve was removed and a mosaic valve 19 mm was implanted instead during the same day 30-apr-2021.The additional extracorporeal circulation time: 2 hours 12 minutes.The additional cross clamp time: 1 hour 28 minutes.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11898712
• MDR Text Key: 266664385
• Report Number: 3004478276-2021-00167
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230422
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 59