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

Model Number PVS25

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 05/02/2014

Event Type  Injury  

Manufacturer Narrative

This event was reported to the manufacturer through the sure avr clinical registry.The manufacturer requested the internal clinical review of this event which assessed as device related.Not yet determined if device available.

Event Description

This event was notified to the manufacturer through the sure avr clinical registry: a perceval size25mm was implanted on (b)(6) 2014 via median-sternotomy.Post-dilatation ballooning was done.On (b)(6) 2014, the patient was re-operated, the perceval device was explanted and a mitroflow aortic heart valve size 23 was implanted.Reoperation was performed due to the perceval device late dislodgement due to malpositioning as reported by the site.

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.Based on the document review performed, no manufacturing deficits were identified.As the device was not available for analysis, no device investigation could be conducted.However, in the event narrative provided, the event was attributed to malpositioning.The root cause of the event can therefore be reasonably attributed to user error.Device not available.

Event Description

This event was notified to the manufacturer through the sure avr clinical registry: a perceval size25mm was implanted on (b)(6) 2014 via median-sternotomy.Post-dilatation ballooning was done.On (b)(6) 2014, the patient was re-operated, the perceval device was explanted and a mitroflow aortic heart valve size 23 was implanted.Reoperation was performed due to the perceval device late dislodgement due to mal-positioning as reported by the site.The patient was alive as of (b)(6) 2016 (last follow-up).

• 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 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7102436
• MDR Text Key: 94352379
• Report Number: 3005687633-2017-00134
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

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: Physician
• Device Expiration Date: 02/18/2017
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2014
• 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): Hospitalization; Required Intervention
• Patient Weight: 60