MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L FREEDOM SOLO PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	ART23SG
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	03/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The valve was received for analysis on may 04, 2017.Analysis is currently underway.
Event or Problem Description
During surgery on (b)(6) 2017, it was noticed that the commissure between right and non-coronary cusps were not at the same height, however, all commissures however were at same distance from each other.The surgeon decided to implant solo 23mm valve and after declamping the aorta, a central leak 2/4 was noticed on echocardiogram.Therefore the valve was explanted and a perimount size 21 valve was implanted.The delay in surgery was about 60 minutes.The patient is doing well now and has returned home.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device was performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Upon receipt of the device, visual and dimensional analyses were performed.The visual inspection confirmed the absence of any non-compliance, and the dimensional analysis confirmed that the size of the valve matched the valve's documentation.No device failure was detectable from the performed analyses.Furthermore, according to the customer narrative, the solo 23 mm was replaced with a perimount 21 mm.This suggests that the original valve was oversized.As such, the event is deemed to be a miss sizing, and therefore not device related.

• Brand Name: FREEDOM SOLO PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada per crescentino snc; saluggia
• MDR Report Key: 6578114
• Report Number: 3005687633-2017-00044
• Device Sequence Number: 16370119
• Product Code: LWR
• UDI-Device Identifier: 00896208000382
• UDI-Public: (01)00896208000382(240)ICV0902(17)200801
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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
• Operator of Device: Physician
• Device Expiration Date: 08/01/2020
• Device Model Number: ART23SG
• Device Catalogue Number: ICV0902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 89