MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL ANNULOFLEX ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

Model Number	AF-836
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, an annuloflex ring af-836 was implanted and explanted on the same day on (b)(6) 2021.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this 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.Since the device was not returned to the manufacturer, no further investigation on the device could be possible.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified.The manufacturer attempted to retrieve additional information on the event, but no further information has been provided to date.Should the manufacturer receive additional information in the future, a follow up report will be submitted.Based on the additional information provided, it was reported that the device was explanted due to an unsuccessful repair of the mitral valve; a full replacement was consequently performed.Based on corcym clinical experience, an intra-operative explant of a mitral ring followed by total mitral valve replacement is attributable to patient factors that precluded adequate repair with an annuloplasty ring.As such, the event is not related to a deficiency of the device and the root cause is deemed related to the patient conditions.Given that the patient remained stable throughout the delay in procedure, with a good outcome after surgery, there is no indication that an adverse event has occurred.As such, no further investigation is required at this time.
Event or Problem Description
Per additional information received, it was reported that the patient was admitted to the hospital on (b)(6) 2021 due to shortness of breath, orthopnea and paroxysmal nocturnal dyspnea.The tee performed on (b)(6) 2021 revealed severe mitral regurgitation (mr), myxomatous degeneration and ruptured posterior mitral valve leaflet chordae.On (b)(6) 2021, the mitral valve was initially repaired by sewing the flail segment to p2 and by implanting a size 36 carbomedics annuloflex band.After weaning from bypass, the tee showed a very stiff posterior leaflet and 2 jets of mild mr.As it was believed that this would worsen over time, a decision was made to proceed with a full mitral valve replacement and a size 31 mm st jude epic bioprosthesis valve was ultimately implanted.The patient tolerated the procedure well and was discharged to home on (b)(6) 2021 in stable conditions.

• Brand Name: ANNULOFLEX ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11794641
• Report Number: 1718850-2021-01067
• Device Sequence Number: 3869324
• Product Code: KRH
• UDI-Device Identifier: 08022057013651
• UDI-Public: (01)08022057013651(240)AF-836(17)250419
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021
• Report Date (Section F): 04/08/2021

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: 04/19/2025
• Device Model Number: AF-836
• Device Catalogue Number: AF-836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: 67 YR