MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. ANNULOFLEX MITRAL ANNULOPLASTY RING

Model Number	AF-830
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is being reported in a conservative manner due to the limited information available on the device involvement and the patient's impact.Device discarded.
Event or Problem Description
On (b)(6) 2019, an implant attempt of an annuloflex size 30 ring occurred.However, it is reported that the ring was implanted, explanted and wasted.No other information is currently available.
Additional Manufacturer Narrative
Sections changed: 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.The manufacturer attempted to follow up with the site to retrieve additional details on the events.However, no information has been received to date.Since the device was wasted, no further investigation is possible at this time.Therefore, based on the limited information available, it is not possible to establish the root cause of the event.If additional information will be received, the case will be re-assessed and a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2019, an implant attempt of an annuloflex size 30 ring (af-830) and an annuloflex size 28 (af-828) occurred.However, it is reported that the rings were implanted, explanted and wasted.No other information is currently available.
Event or Problem Description
On (b)(6) 2019, an implant attempt of an annuloflex size 30 ring (af-830) and an annuloflex size 28 (af-828) occurred.However, it is reported that the rings were implanted, explanted and wasted.No other information is currently available.

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8384226
• Report Number: 3005687633-2019-00152
• Device Sequence Number: 16726035
• Product Code: KRH
• UDI-Device Identifier: 08022057013620
• UDI-Public: (01)08022057013620(240)AF-830(17)230507
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2019

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: Health Professional
• Device Expiration Date: 05/07/2023
• Device Model Number: AF-830
• Device Catalogue Number: AF-830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2019
• Supplement Date Received by Manufacturer: 03/02/2019; 04/05/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 03/02/2019; 04/05/2019
• 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
• Patient Age: 82 YR