MAUDE Adverse Event Report: CORCYM S.R.L. ANNULOFLEX MITRAL ANNULOPLASTY RING

Model Number	AF-834
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, an annuloflex annuloplasty mitral ring af-834 was attempted to be implanted.The annuloflex af-834 was cut at anterior cut points by the site cv resident.Fraying occurred at a3-p3 portion of ring.The ring was discarded.Another af-834 ring was opened and this time the surgeon removed anterior portion by cutting annuloflex anterior cut points.There was no fraying of ring and this ring was implanted with no incident.The procedure went well with 10 minutes increase in cross-clamp time.The patient had normal recovery.Based on the information reported by the physician, the event may be due to use error occurring at the time of the removal of the anterior portion of the ring.-.
Additional Manufacturer Narrative
Updated sections: b4, g3, g6, h1, h2, h3, h6 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 device was retrieved for evaluation.The ring appeared in general good condition, excepting in one of the extremities that appeared frayed.After decontamination, the device was visually inspected by means of microscope.The results showed that the dacron fabric frayed in a morphology congruent with an inadvertent contact with the blade of the scalpel or scissor when the anterior portion of the ring was removed.Based on the investigation performed, the root cause of the reported event can be traced to an inadvertent use error in line with the medical judgment received.Furthermore, no material deficits were identified during the document review and inspection on the returned device.No serious injury or adverse event for the patient occurred.As such, no further investigation is warranted at this time.

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12522347
• Report Number: 3005687633-2021-00155
• Device Sequence Number: 4584508
• Product Code: KRH
• UDI-Device Identifier: 08022057013644
• UDI-Public: (01)08022057013644(240)AF-834(17)260103
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• 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: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2021

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: 01/03/2026
• Device Model Number: AF-834
• Device Catalogue Number: AF-834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown