MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS REDUCED; REDUCED SIZE 23 AORTIC

Model Number	R5
Medical Device Problem Codes	Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); No Information (3190)
Date of Event	10/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient tracking form does not indicate the reason for the valve explantation.The present case has been deemed reportable in conservative way.The reintervention, without a clear reported reason, can be considered potentially a serious injury.On basis of the information available, is not clear if the replacement of the r5-023 with a r5-025 (same brand and model but bigger size) was due to a potential deficiency in the performances or to anatomical and/or phisiological reasons.The review of the device history record is ongoing.Valve not available.
Event or Problem Description
Information from patient trkg ((b)(6) 2016): we received a 2nd prf for patient ((b)(6) male, dob (b)(6) 1969) who has a r5-023 implanted in 2013.Details as: r5-023 sn # (b)(4) implanted on (b)(6) 2013 at (b)(6) med ctr (b)(6).R5-025 sn # (b)(4) implanted on (b)(6) 2016 at (b)(6) med ctr (b)(6).
Additional Manufacturer Narrative
Based on the information provided, this was a case of paravalvular leak.A carbomedics reduced aortic valve, size 23 was originally implanted.This was later explanted and replaced with a carbomedics reduced aortic valve, size 25.This suggests that the event may be attributable to a mis-sizing.However, given that the device was not available for analysis, no further investigation can be conducted at this time.
Additional Manufacturer Narrative
The manufacturer received the following additional information on (b)(6) 2017.The valve was removed due to a paravalvular leak.The patient was discharged without incident and is doing well to date.A complete manufacturing and material records review for the device was performed on (b)(6) 2017.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the review conducted, no manufacturing deficits were identified.However, as the device is not available for return, no further investigation can be performed at this time, and the root cause of the event cannot be determined.The manufacturer is aware of the late reporting of this additional information.Device not available for return.

• Brand Name: CARBOMEDICS REDUCED
• Common Device Name: REDUCED SIZE 23 AORTIC
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 6126944
• Report Number: 3005687633-2016-00021
• Device Sequence Number: 786811
• Product Code: LWQ
• UDI-Device Identifier: 08022057012784
• UDI-Public: (01)08022057012784(240)R5-023(17)160702
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2017

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: No Information
• Device Expiration Date: 07/02/2017
• Device Model Number: R5
• Device Catalogue Number: R5-023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: 11/16/2017; 11/16/2017
• Initial Report FDA Received Date: 11/24/2016
• Supplement Report FDA Received Date: 11/17/2017; 11/17/2017
• 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: 47 YR