MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. MEMO 4D SEMIRIGID ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

Model Number TBD

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Livanova performed a review of the instruction for use (ifu) for the memo 4d semirigid annuloplasty ring.The results confirmed the presence of a dedicated section (i.E.Section 9.3.3.Use of the holder referred also in section 9.3.2, point d) which provides clear and detailed instructions to the safe and correct use of the device holder (defined as disk+template).Specifically, after detailing two possible configurations for the removal of the holder, this section includes a note of caution to further stress the importance of the holder removal: 'both parts of the holder must be removed from the device after implant and discarded.The implantation of the holder or its presence in the implant site may result in serious injury to the patient, or death.' based on the review performed, no deficiency has been identified in the instructions provided.The root cause of the reported event can be reasonably attributed to an off-label use of the device.Should additional information become available on this event, a follow up report will be submitted.Disposition unknown, unable to follow up.

Event Description

The manufacturer was informed that a patient received a memo 4d (implant date unknown).The blue template (holder) was reportedly not removed during the surgery, thus remaining implanted in the patient.The patient received reoperation in another center where the template was removed.It is reported that the patient required another surgery (not related to the memo 4d), and on this occasion, it was identified that the template was implanted in the patient.No symptoms were previously noted.

• Brand Name: MEMO 4D SEMIRIGID ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, british columbia V5J5M-1 ; CA V5J5M1
• MDR Report Key: 9447038
• MDR Text Key: 188222212
• Report Number: 3005687633-2019-00269
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention