MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVES

Model Number PVS21

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Aortic Insufficiency (1715); Pulmonary Edema (2020)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this event occurred in (b)(6) and the device is manufactured at our sister site - sorin group (b)(4).It therefore does not have a udi# as perceval sutureless aortic heart valves manufactured at our sister site are not sold in usa.

Event Description

A perceval valve size 21 mm that was implanted on (b)(6) 2017 was explanted on (b)(6) 2017 due to a dislodged valve.The physician commented that this may have been due to over-sizing.An edwards perimount device (size unknown) was then implanted.Prior to explant the patient presented with pulmonary edema and aortic insufficiency.The patient outcome is good.

Manufacturer Narrative

A gross examination was completed and returned the following results.The valve was received in the provided plastic jar without any kind of storage liquid.The valve was in dry conditions and the pericardium tissue appeared dehydrated.The visual inspection in according to the procedure qbf-031(current revision at the time of manufacture and release), was not possible due to the precarious receiving conditions of the valve.As indicated in the gross examination, the pericardium tissue resulted dehydrated.Echo images pertaining to the case could not be reviewed as confirmed by medstar external reviewer dec.13, 2017.A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The valve was replaced with an edwards perimount of unknown size so the oversizing cannot be confirmed.Because the valve was received in a condition where no evaluations could be performed and the echo records could not be reviewed by medstar the root cause cannot be determined at this time.If further information is received the case will be re-opened for investigation.

Event Description

The manufacturer received additional information about this event through the paper "double valve failure due to perceval sutureless aortic valve migration" by michele rossi and al.A perceval valve size s was implanted on (b)(6) 2017.Both intraoperative transesophageal echocardiography and pre-discharge transthoracic echocardiography demonstrated a well-seated prosthesis with no paravalvular leak.About five months later the patient began referring to increasing dyspnea and fatigue escalating to urgent hospitalization for heart failure exacerbation with pulmonary edema.On physical examination, it was observed that the perceval size s migrated into the left ventricular outflow tract, with part of the valve ring placed onto the native anterior mitral leaflet, creating concomitant severe aortic and mitral insufficiency.A decision was made to explant the valve via full sternotomy on (b)(6) 2017.Intraoperative findings confirmed a downward migration of the valve, with non-adherence of the sinusoidal elements of the perceval prosthesis to the aortic wall for almost half of the valve diameter, in the region between the right and non-coronary sinus.An edwards perimount, magna ease 21mm was implanted with good results.The patient was discharged home on the 10th postoperative day and is doing well at 60 days follow up.It is reported by the authors of the paper that this was only the sixth valve to be implanted.It is also commented that the explanted prosthesis was intact, showing that the failure had been caused by its migration rather than by any early structural valve failure, or infection.It is possible that extensive and asymmetric annulus calcification with suboptimal valve anchoring might have played a role in the genesis of this unusual complication, although no signs of valve malpositioning appeared during the first hospital admission.

Manufacturer Narrative

Based on the additional information received, no device deficiencies were identified after the perceval explant.The authors speculate on the possibility that the patient's factors (extensive and asymmetric annulus calcification) combined with a suboptimal valve anchoring might have played a role in the device postoperative dislodgment.However, because of the limited investigation that was made possible, the root cause of the reported event could not be confirmed and remains unknown at this time.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada crescentino snc; saluggia,, vc
• MDR Report Key: 6979413
• MDR Text Key: 90317539
• Report Number: 3005687633-2017-00107
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 02/05/2019

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
• Device Operator: Physician
• Device Expiration Date: 12/11/2017
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 01/10/2018; 05/03/2018; 01/07/2019
• Supplement Dates FDA Received: 02/09/2018; 05/04/2018; 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR