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

Model Number PVS23

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

Patient Problem No Information (3190)

Event Date 08/28/2012

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted in the patient, a full analysis on the prosthesis cannot be performed.A complete manufacturing and quality 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.Further investigation is ongoing.Device not explanted.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2012, a (b)(6) years old female patient received a pvs23 to replace the native (bicuspid) stenotic aortic valve.The procedure was performed through mini-thoracotomy and no concomitant procedures were performed.The valve was successfully implanted.However, on the same day, the patient underwent an open surgical procedure due to non-structural valve dysfunction.The valve was not explanted.On (b)(6) 2012, a perivalvular leak of 1+ was observed.At discharge on (b)(6) 2012, the tte showed a perivalvular leak of 1+.On (b)(6) 2013, perivalvular and central leaks were observed.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2012, a 73 years old female patient received a pvs23 to replace the native (bicuspid) stenotic aortic valve.The procedure was performed through mini-thoracotomy and no concomitant procedures were performed.A device dislocation was detected at the end of the surgical procedure.The patient was treated by repositioning of the perceval, and the repositioning occurred before moving the patient in the intensive care unit.The surgical procedure was successfully performed and no complications were reported.The device functionality was monitored and a perivalvular leak of 1+ was observed post-operatively ((b)(6) 2018).On 12 feb 2013, perivalvular and central leaks of 1+ were observed.

Manufacturer Narrative

Based on the clarifications received from the site, the re-intervention occurred due to device dislocation detected at the end of the surgery.However, it is not possible to confirm the exact root cause of the device dislocation at this time.Furthermore, it should be recognized that the perceval ifu includes a precaution, stating that "data from clinical or in vitro testing are not available to establish the safe use of the perceval valve in patients with congenital bicuspid aortic valve.Therefore, careful consideration of its use is recommended in such cases, especially when the depth of the 2 sinuses in the lvot is unequal." it could be possible that the patient's anatomy may have contributed to the reported 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: 8192537
• MDR Text Key: 131304891
• Report Number: 3005687633-2018-00243
• 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: 12/21/2018

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: 09/07/2014
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 55