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

Model Number	SMD26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on limited information the manufacturer is reporting in a conservative manner.Not yet determined if device available.
Event or Problem Description
On (b)(6) 2017 the manufacturer was notified through patient tracking of a memo3d #28 that was implanted on (b)(6) 2017.Patient tracking was previously aware of a memo3d #26 that was implanted in the same patient on (b)(6) 2017.
Additional Manufacturer Narrative
More than three follow-up attempts were made to obtain further information regarding the events surrounding the explant of this device; however, the manufacturer was unable to obtain any further information.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 manufacturer was unable to follow up on this event, the device was not returned for analysis and no further investigation could be performed.However, according to the information available, a memo3d #26 was replaced by a memo3d #28.Based on this information, it is possible that a mis-sizing contributed to this event; however, the root cause cannot be definitively stated.Should further information become available at a later date, appropriate investigative actions will be taken.Unable to follow up; not returned.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada crescentino snc; saluggia,, vc 13040 ; IT 13040
• MDR Report Key: 6997871
• Report Number: 3005687633-2017-00114
• Device Sequence Number: 13916211
• Product Code: KRH
• UDI-Device Identifier: 08022057013101
• UDI-Public: (01)08022057013101(240)ICV0967(17)210530
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• 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): 12/14/2017

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: 05/30/2021
• Device Model Number: SMD26
• Device Catalogue Number: ICV0967
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR