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

Model Number PVS21

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Aortic Insufficiency (1715)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer ((b)(4)) and it was received on 21 jun 2019.The returned valve was received with blood traces on the pericardium but still in general good conditions.

Event Description

On (b)(6) 2019, a pvs21 implant attempt occurred through mini-sternotomy (third ic), percutaneous venous cannulation and central reinjection.The ascending aorta was of normal size, but diffusely calcified.Antegrade pledge and aortotomy at the level of the fat streak were performed.The calcified native valve was reportedly difficult to resect.After sizing, it was decided to implant a size s.The annulus measured 20mm.The implant occurred without problems and, after clamp removal, sinus rhythm was restored and the valve was functioning well with only a trivial perivalvular leak.However, at weaning from bypass, during closure, a sudden onset of massive aortic insufficiency was noticed, caused by the 'pop-up' of the valve.A full sternotomy was consequently performed, and the cardiopulmonary bypass (cbp) was re-started.The pvs21 was removed, the calcification of the annulus was resected and a new perceval valve, size m (pvs23), was successfully implanted.The patient was easily weaned from cpb in atrio-ventricular block ii (bav2).No aortic insufficiency was observed on echo.The patient was extubated within 6 hours and was very stable on postoperative day 1.Total cpb time was 61 + 45', total cross clamp time was 46 + 29'.

Manufacturer Narrative

Fields changed: b4, b5, g4, g7, h1, h2, h3, h6.The visual inspection performed on the returned prosthesis confirmed the absence of pre-existing defect.The dimensional verification confirmed that the returned pvs 21/s valve meets the specifications.Furthermore, the manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(6), and its nitinol stent component, as they pertain to the reported event, were retrieved and reviewed by 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.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device.The root cause can be reasonably attributed to a non-proper decalcification at the annulus level, as confirmed by the site's assessment.

Event Description

On (b)(6) 2019, a pvs21 implant attempt occurred through mini-sternotomy (third ic), percutaneous venous cannulation and central reinjection.The ascending aorta was of normal size, but diffusely calcified.Antegrade pledge and aortotomy at the level of the fat streak were performed.The calcified native valve was reportedly difficult to resect.After sizing, it was decided to implant a size s.The annulus measured 20mm (intraoperative data).The implant occurred without problems and, after clamp removal, sinus rhythm was restored and the valve was functioning well with only a trivial perivalvular leak.However, at weaning from bypass, during the closure, a sudden onset of a massive perivalvular leak was noticed, caused by the "pop-up" of the valve.A full sternotomy was consequently performed, and the cardiopulmonary bypass (cbp) was re-started.The pvs21 was removed, the calcification of the annulus was resected and a new perceval valve, size m (pvs23), was successfully implanted.The patient was easily weaned from cpb in atrio-ventricular block ii (bav2, which was confirmed to be a transient one)).No aortic insufficiency was observed on echo.The patient was extubated within 6 hours and was very stable on postoperative day 1.Total cpb time was 61 + 45 ', total cross clamp time was 46 + 29'.Based on the medical judgment, the implant failure of the pvs21 was caused by the residual calcification at the annulus level, which was not properly de-calcified before pvs21 implant.No mis-sizing was suspected and no perceived issue with the device was reported.The patient had a good outcome after the surgery.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8774116
• MDR Text Key: 150543151
• Report Number: 3004478276-2019-00202
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230321
• 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
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 71