MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS25

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

Dhr review has been completed.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.

Event Description

On (b)(6), 2021 a (b)(6) year old patient received a perceval pvs25 sutureless aortic heart valve, size l.After closing the aorta and taking the patient off bypass toe identified that one of the leaflets was not moving.The perceval l valve was removed and a new perceval l valve was implanted.Post op toe showed all 3 leaflets coapting correctly.Upon examination of the perceval valve one leaflet appeared to have restricted mobility.

Manufacturer Narrative

After decontamination, the valve was visually inspected without highlighting elements of non-conformity, according to the specifications.The height of each leaflet has been verified by means the specific tool and it resulted in conformity.In order to allow an exhaustive evaluation of the functional behavior, the returned valve underwent hydrodynamic testing in simulated physiological conditions.The effective orifice area (eoa) at 70 bpm, 5 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 3.51 cm2, well above the iso 5840 minimum requirement 1.45 cm2.No anomalies were observed during the open/close cycle in normotensive conditions and hypotensive conditions.No regurgitation was observed during the laboratory tests.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device because the claimed issues were not observed during the investigation carried out (i.E.Hydrodynamic test).Procedural or patient-factors related might have contributed to the reported event.Ultimately, a definitive root cause cannot be established at this time.

Event Description

On (b)(6) 2021 a 78 years-old patient received a perceval pvs25 sutureless aortic heart valve, size l.After closing the aorta and taking the patient off bypass toe identified that one of the leaflets was not moving.The patient was put on bypass again and the perceval l valve was removed.The annulus was re-sized and the correct size to implant was again l.No additional debridement or annular restructuring was reportedly performed prior to the second implant of the new perceval l valve.Post op toe showed all 3 leaflets coapting correctly.Upon examination of the perceval valve upon explant, one leaflet appeared to have restricted mobility.The patient remained stable during the event.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11682525
• MDR Text Key: 253105540
• Report Number: 3005687633-2021-00113
• 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
• Report Date: 05/20/2021

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: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR