MAUDE Adverse Event Report: SORIN GROUP CANADA INC. MITROFLOW AORTIC PERICARDIAL HEART VALVE; TISSUE, HEART VALVE

Model Number LXA

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Cardiac Arrest (1762)

Event Date 12/20/2011

Event Type  Other  

Event Description

The mfr was notified on (b)(6) 2014 that a mitroflow valve (unk serial) was explanted after 1.5 years.Pt presented with syncope, cardiac arrest in cath lab, peak/mean gradients 88 and 52.The above info was obtained from a summary table provided by the surgeon.The serial was obtained from sorin's pt tracking records.

Manufacturer Narrative

Device evaluated by mfr.Device was not returned to sorin for investigation.Method: the results of the device history record review confirmed the device met all material, dimensional, and performance requirements at the time of mfr and release.The function test video review confirmed that the valve meets all the established performance criteria.Results code: no definitive results at this time.Conclusion: no conclusion can be drawn at this time as device is unavailable for eval.Additional comments: please note that sorin group reached out to (b)(6) in the us in (b)(6) 2014 after notification of multiple events reported by (b)(6) to obtain more info on the use of the mitroflow valve in pediatric pts.Dr (b)(6) was willing to provide sorin group info on the six pediatric pts that received a mitroflow valve.From the six pts 4 of the valves have been explanted, and 2 are still implanted.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE, HEART VALVE
• Manufacturer (Section D): SORIN GROUP CANADA INC.; burnaby, bc ; CA
• Manufacturer (Section G): SORIN GROUP CANADA INC., MITROFLOW DIV; 5005 north fraser way; burnaby, bc V5J 5M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1 ; 4125696
• MDR Report Key: 4284124
• MDR Text Key: 5229696
• Report Number: 3004478276-2014-00024
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2015
• Device Model Number: LXA
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2010
• 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: 11 YR