MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD; STANDARD SIZE 25 MITRAL

Model Number	M7
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/20/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device history record review is ongoing.
Event or Problem Description
During a procedure, one of the leaflets became stuck after the heart was closed.On (b)(6) 2016: a procedure was started to perform mitral valve replacement (mvr) and coronary artery bypass grafting (cabg) at two sites.For the mvr procedure, the carbomedics m7-027 (sn: (b)(4) - object of a different initial report) was implanted into the mitral annulus.After the leaflets were confirmed to be functioning normally using a leaflet tester, the heart was closed.While the heart-lung machine was still operating, one of the leaflets was found to be stuck.The heart was re-opened and the valve was tested again using a leaflet tester.The result was that the leaflets were functioning normally.However, after the heart was closed again, the stuck of the leaflet recurred.The carbomedics m7-027 was replaced with the carbomedics m7-025 (sn: (b)(4) - object of this initial report).Just in case, this m7-025 valve was rotated to be in a different orientation and implanted by a different suturing technique from the previous one.After the leaflets were confirmed to be functioning normally using a leaflet tester, the heart was closed.Similarly to the previous valve, one of the leaflets was found to be stuck while the heart-lung machine was still operating.Eventually, a bioprosthetic mitral valve was implanted instead of the carbomedics valves.After the procedure was done, the patient was discharged from the operating room with percutaneous cardiopulmonary support (pcps).On (b)(6) 2016: in the morning, the patient died being unable to wean off pcps.Additional note: during the mvr procedure with each carbomedics valve, it was confirmed using a leaflet tester that there was no obstruction in the other side of the valve.Surgeon's comments: although no device defect is suspected on both carbomedics valves, it still cannot be identified what directly caused the insufficiency of the opening and closing functions of the leaflets.Just in case, the hospital would like to have the valves analyzed.In regard to the cause of death, as the patient originally had a coronary disease and there was probably an effect of the long-time use of extracorporeal circulation, it is considered that the patient was unable to wean off pcps due to cardiac hypofunction and cardiac arrest.Notes from the distributor (b)(4): since no device defect is suspected, this case is not to be reported to the (b)(6).
Additional Manufacturer Narrative
An independent echo core-lab reviewed the received echocardiographic documentation and the results were: "mechanical mitral valve implanted.There are intermittent events of a disk becoming immobile, in all cases the medial one.Given the limited images and significant artifacts it is unclear the etiology causing the events, but no clear thrombus is seen.Cannot see the lv cavity, likely very small during these exams." the review of device history records confirmed that the prosthesis sn (b)(4) was conforming to all specifications, at the time of manufacture and release, including a function test of the valve in a hydrodynamic tester.The visual inspections performed on the returned valve confirmed the absence of manufacturing defects.The subject prosthesis was characterized by regular mechanical, kinematic and hydrodynamic behaviour as determined by means of hydrodynamic tests performed on the returned valve.Phenomena of partial leaflet immobilization, that could induce an opening/closing difficulties immediately after implant, have been described in literature.In the present case, no explanation for the reported events can be given on the basis of our experimental evaluation, because no mechanical malfunction could be reproduced in our laboratories.Note: same patient and the same surgery session of the rep.# 3005687633-2016-00013.

• Brand Name: CARBOMEDICS STANDARD
• Common Device Name: STANDARD SIZE 25 MITRAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 5878887
• Report Number: 3005687633-2016-00014
• Device Sequence Number: 463839
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)190404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2016

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: 04/04/2019
• Device Model Number: M7
• Device Catalogue Number: M7-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2016
• Supplement Report FDA Received Date: 10/26/2016
• 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: Death
• Patient Age: 54 YR
• Patient Weight: 44