MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING

Model Number	MRCS37
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was suspected that the blue or yellow suture on the rechord was caught in the tying suture, which prevented the release of the guiding suture.Device not explanted.
Event or Problem Description
A mitral annuloplasty that did not require work on the chordae was performed using a memo 3d rechord.After positioning the ring, the physician was unable to pull the blue string to release the yellow guiding suture on the ring.The surgery was completed and the yellow suture was left in place.No negative patient impact was reported, and the devices functionality was reported to be unaffected by the event.
Additional 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.Given that the device was not available for analysis, no device investigation could be performed.However, according to the information provided, it was suspected that the blue or yellow suture of the rechord became caught in the tying suture, and therefore could not be released.As such, this event can reasonably be attributed to user error.Furthermore, in the instructions for use of the memo3d, "in case the replacement of the chordae tendineae is not necessary, remove the rcs [rechord system] from the annuloplasty ring before its implantation discard the two threads." as such, the event can also be attributed to a failure to follow instructions.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7089269
• Report Number: 3005687633-2017-00121
• Device Sequence Number: 19199058
• Product Code: KRH
• UDI-Device Identifier: 08022057015129
• UDI-Public: (01)08022057015129(240)ICV1337(17)211019
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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
• Operator of Device: Physician
• Device Expiration Date: 10/19/2021
• Device Model Number: MRCS37
• Device Catalogue Number: ICV1337
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/26/2018
• 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: Other