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

Model Number PVS21

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 01/03/2014

Event Type  Injury  

Manufacturer Narrative

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.Since the device remains implanted in the patient, further investigation on the prosthesis cannot be performed.

Event Description

The manufacturer was informed on the event through the (b)(6) database: on (b)(6) 2014, an (b)(6) female patient received a perceval pvs21 to replace the native stenotic aortic valve.The procedure was performed in median sternotomy.A cabg was also performed during the same procedure.On the same day, the site reports a device dislodgment.As such, a reintervention occurred and the patient underwent an open surgical procedure without device explant.The patient was discharged on (b)(6) 2014, with a good device functionality (mean gradient was 14mmhg, and no central/perivalvular leaks were observed).The functionality of the prosthesis was monitored yearly since its implant, with the following findings: in (b)(6) 2015, the echo shows a mean gradient of 14mmhg, with no central/perivalvular leaks; in (b)(6) 2016, the echo reports a mean gradient of 10mmhg, with no central/perivalvular leaks; in (b)(6) 2017, the reported mean gradient was 12mmhg, and no central/perivalvular leaks were observed.Lastly, in (b)(6) 2018, the echo showed a mean gradient of 4mmhg, no perivalvular leak and a central leak of 1+ (traces).The site reports that the patient ultimately died (b)(6) 2018 due to non-cardiovascular mortality.Since no autopsy was performed, the device was not explanted (not valve-related).

Event Description

The manufacturer was informed on the event through the sure avr database.On (b)(6) 2014, an 84 years old female patient received a perceval pvs21 to replace the native stenotic aortic valve.The procedure was performed in median sternotomy.A cabg was also performed during the same procedure, prior to the aortic valve replacement.At the end of the procedure, during the routine intraoperative tee, a paraprosthetic leak was detected.The aortotomy was again performed and the valve was found dislodged in supra-annular position.It is reported that no cpr nor any other manipulation of the heart was performed after the perceval implant.Consequently, an open surgical procedure was performed but the device was not explanted (device repositioned).The site reports that the severe annulus calcification might have been the cause of the difficulties encountered at the implant.The patient was discharged on (b)(6) 2014, with a good device functionality (mean gradient was 14mmhg, and no central/perivalvular leaks were observed).A good valve functionality was also observed during the yearly follow up visits performed between 2015 and 2018: the mean gradient was 14mmhg, 10mmhg, 12mmhg, 4mmhg, respectively; no central/perivalvular leaks were detected in neither visit, except for the one in 2018 where a central leak 1+ was observed (as previously reported by the site, regurgitation 1+ is considered a mild regurgitation without hemodynamic consequences).The site reports that the patient died on 05 oct 2018 due to non-cardiovascular mortality (not valve-related).Since no autopsy was performed, the device was not explanted.

Manufacturer Narrative

Since the device was not explanted during the re-intervention and since a good device functionality was observed during the yearly follow-up visits, the device could be reasonably excluded as contributory factor of the event.As reported by the site, it is possible that the severe calcification of the patient's annulus may have contributed to the event.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8332956
• MDR Text Key: 135942944
• Report Number: 3005687633-2019-00130
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 53