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

Model Number M7-025

Device Problem Positioning Problem (3009)

Patient Problem Mitral Insufficiency (1963)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Device being sent to manufacturer.

Event Description

On (b)(6) 2019 a patient received a carbomedics standard mechanical mitral valve m7-025.It was reported that during the procedure the patient had poor hemodynamics after suturing.The site removed the valve, and it was found that the connection position between valve holder and valve was reversed.The site reported the patient/user was not affected.

Manufacturer Narrative

The manufacturer received the device for analysis on april 10, 2019.A gross investigation was performed.The returned valve was received mounted on the holder from the outflow side, even the holder sealing wire was broken.The sewing cuff of the valve and the holder too were blood stained.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.In particular the qc inspection as per (b)(4) "holder assembly / pre-sterile packaging inspection" performed on march 26, 2018.

Manufacturer Narrative

Updated event information received on april 15, 2019.The following information has been included.On (b)(6) 2019 a patient received a carbomedics standard mechanical mitral valve m7-025.It was reported that during the procedure the patient had poor hemodynamics after suturing.The site removed the valve, and it was found that the connection position between valve holder and valve was reversed.The site reported this was the orientation the device was received in.The device was replaced with a second carbomedics standard m7-025, sn: (b)(4).The site reported the patient/user was not affected, recovered and was discharged.Surgery time increased around 2.5 hours due to this error.After the decontamination the valve was visually inspected by means of photographs and leica s8ap0 stereoscopic microscope; the sewing cuff presented alterations on the fabric surface reasonably correlated to suture stitches.In addition the shape and morphology, of the mentioned alterations, are suggesting a direction of the needle passage from the outflow side toward the inflow side of the cuff.This is in accordance with the normal suturing procedure when a mitral valve is connected to the holder in the correct position.In addition the result of the device history record review confirmed that the returned product satisfied all material, dimensional and performance standards, required for a carbomedics standard mitral m7-025 at the time of manufacture and release, including the qc inspection as per (b)(4) "holder assembly / pre-sterile packaging inspection" performed on march 26, 2018.This kind of inspection (final assembly video inspection system) is focused to guarantee that the valve is correctly mounted on the holder according to the implant position expected.No other manipulations are performed after this control and the final packaging and sterilization.The returned valve met the specification of the qc inspection as per (b)(4) "holder assembly / pre-sterile packaging inspection" performed on march 26, 2018.The marks of suture stitches, found on the cuff surface, are reasonably a proof of the suture of a mitral prosthesis correctly mounted on the holder.This confirms the results of the dhr review that showed evidence that the valve meet the qc control related to the correct assembly on the holder.Based to the performed analysis there are no elements to confirm the customer complaint.The conclusion of the manufacturers investigation is thus no problem found.

Event Description

On (b)(6) 2019 a patient received a carbomedics standard mechanical mitral valve m7-025.It was reported that during the procedure the patient had poor hemodynamics after suturing.The site removed the valve, and it was found that the connection position between valve holder and valve was reversed.The site reported this was the orientation the device was received in.The device was replaced with a second carbomedics standard m7-025, sn: (b)(4).The site reported the patient/user was not affected, recovered and was discharged.Surgery time increased around 2.5 hours due to this error.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8480601
• MDR Text Key: 140875383
• Report Number: 3005687633-2019-00159
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)230224
• Combination Product (y/n): N
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/24/2023
• Device Model Number: M7-025
• Device Catalogue Number: CPHV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention