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

Model Number PVS27

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Folded (2630)

Patient Problem Aortic Insufficiency (1715)

Event Date 02/14/2017

Event Type  Injury  

Event Description

A perceval valve was implanted on (b)(6) 2017 via full sternotomy concomitant with cabg (saphenous vein graft).Moderate central leak was detected in the post-operative tee.On (b)(6) 2017, reintervention was taken to explant the valve due to progredient severe aortic valve regurgitation.The patient also received red blood cell transfusion.The issue was resolved on the same day.

Manufacturer Narrative

The returned product was received in an explant kit and in the provided plastic jar (, it was received stained of blood with the third leaflet folded down.After decontamination, the valve was visually inspected highlighting an irregular shape of the valve , reasonably due to the manipulation during the implant / explant steps.Moreover, the returned valve still presents blood residues and the third leaflet is folded down, appearing open.These aspects of the returned valve can be reasonably correlated to a kinking occurred in the area correspondent to the inflow crown of the nitinol structure between the i and ii posts, causing a permanent deformation to the pericardium tissue.No rupture of the stent was highlighted with the x-ray analysis and no irregularity was identified with the p-np gauge test.During the simulation of the valve deployment, no problems were encountered with collapsing and ballooning of the returned valve in the maximum annulus diameter (26.5 mm) acceptable for the size 27, except the flat area already previously identified.Otherwise, the returned valve was deployed in the minum annulus diameter (25 mm) of the size 27 for two time.The first and second time of the positioning of the valve in the minimum annulus diameter: at the second attempt, the returned valve showed a deformed geometry of the leaflet on the outflow side (curling of the stent and pericardium) and an unusual open position of the third leaflet in correspondence of a kinked area.The folding of the inflow ring was observed as result of a localized radial force applied during the simulation.We have to take in consideration that the valve was implanted in an annulus reasonably smaller than minimum required, as confirmed to the fact that a perceval size 25/l was finally implanted instead.The observed behavior of tendency to invaginate with a radial load is reasonably due to the deformation previously occurred during the implanting time and the permanence in this status for 5 days.The not perfect circularity observed at the explant is consistent with the shape documented at the preliminary incoming inspection (gross examination).It corresponds to the area where the kinking reasonably occurred and persisted during the 5 days of functioning in a small annulus.The memorized deformation lead to a stent kinking also when deployed on the minimum size per ifu (i.E.#25) and in concomitance with a localized force.The observed and reproduced deformation/folding on the inflow ring, is reasonably the root cause of the reported event of aortic regurgitation.The results of the document review for the perceval valve pvs 27 / xl ¿ sn (b)(4)confirmed that the device satisfied all material, dimensional and performance standards required for a perceval valve size 27/xl at the time of manufacture and release, including a function test performed by quality control in a hydrodynamic tester on nov 13, 2015.Review of the data filed in the device history record confirmed that the returned perceval aortic heart valve sn (b)(4) satisfied all material, dimensional, and performance standards required for perceval size 27 / xl at the time of manufacture and release.The visual inspection performed on the returned prosthesis confirmed the absence of manufacturing defects but identified a valve deformation.This deformation is related to the valve implanted for 5 days in suboptimal conditions (annulus smaller than ifu indication) as confirmed by the size of the valve which was then implanted (perceval size 25).The analysis performed with the deployment showed, in particular conditions (i.E.Minimum diameter and radial stress), a valve folding in the same position where the valve deformation was identified and documented in the gross examination.Based on this evidence the root cause of the aortic regurgitation is identified to be related to the valve folding caused by a valve oversizing.

• Brand Name: PERCEVAL SUTURLESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6408401
• MDR Text Key: 70056128
• Report Number: 3004478276-2017-00031
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)191130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR