MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; HEART VALVE, MECHANICAL

Model Number M7-027

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930); Sepsis (2067); Septic Shock (2068)

Event Type  Death  

Event Description

On (b)(6) 2019, a patient received a carbomedics standard mitral m7-027.In the icu, a serious infection (not further specified) was observed in the patient.A potential link with the metal valve (mechanical) was suspected, although this relationship was not further supported by further data.It was reported that the patient passed away but no further details on the cause of death or device relationship were provided.

Event Description

On (b)(6) 2019, a patient received a carbomedics standard mitral m7-027 to replace a biological mitral prosthesis implanted in 2008.A good postoperative course is initially reported.However, between the 7th and 9th pod (postoperative day), the patient had af with high vr, with tachypnea, multiple organ dysfunction (respiratory, renal, liver failure), which resulted in the need for high doses of amines and continuous hemodialysis.Reintubation was necessary, and the patient died on the 10th pod.The causes of death indicated in the death certificate are septic shock, severe sepsis, and undefined-focus infection.

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 (unknown if autopsy performed), no further investigation can be performed at this time.Based on the available information, there is not sufficient evidence to reasonably believe that the devices caused or contributed to the reported event, considering also livanova's sterilization process.However, since no further information was provided on the event (i.E.Type of infection, device functionality, patient¿s clinical history), the root cause cannot be ultimately confirmed and remains unknown at this time.If additional information will be made available in the future, a follow up report will be submitted.

Manufacturer Narrative

Based on the additional information received, it was confirmed that the hospital staff discarded the possibility of a problem related to the product.Therefore, the root cause of this event is considered not related to the device.If further information will be made available, the case will be properly updated.At this time, based on the information available, no further investigation is required.

Event Description

Based on the assessment received from the hospital staff, there was no evidence identified to attribute the patient's infection to the livanova device, which relationship with the event was excluded.The remainder of the information previously submitted remains unchanged.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9324928
• MDR Text Key: 166490468
• Report Number: 1718850-2019-01172
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012722
• UDI-Public: (01)08022057012722(240)M7-027(17)231111
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019,01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: M7-027
• Device Catalogue Number: M7-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 45 YR