MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. MITROFLOW VALSALVA CONDUIT; TISSUE HEART VALVE

Model Number MVC030

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted july 06, 2018 and resubmitted due to missing 3rd acknowledgment.Device disposition presently unknown.

Event Description

On (b)(6) 2018 a mitroflow valsalva conduit was intended for implant.During the procedure the purse string broke and another mitroflow valsalva conduit was implanted as a replacement.

Manufacturer Narrative

The manufacturing and material records for the mitroflow valsalva conduit , model #mvc030 , s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #mvc030) mitroflow valsalva conduit at the time of manufacture and release.

Manufacturer Narrative

The manufacturer followed up with the site three times for additional information but was unable to acquire any further information.A gross inspection was performed on the returned device.The returned material was received in the original carton box that appears slightly damaged.The holder of the mitroflow valsalva conduit is blood stained.The blue monofilament thread of the conduit (purse string suture) is missing but the conduit edge appears slightly frayed, indicating the previous passage of the blue thread.The preliminary visual inspection performed by naked eye showed that the blue thread and the supporting plastic ring were missing.The microscopic visual inspection highlighted a fringed area in correspondence on the position of the blue thread knot and a cut portion, reasonably associated to contact with a blade (i.E.Scissor or scalpel).Based on the event description and to the performed analyses there is no correspondence that could explain the anomalies observed on the returned device.A possible root cause of the event could be reasonably associated to an involuntary maneuver in the cutting of the green thread that caused damage to of both the conduit edge and the blue thread.In the case that the blue thread ruptured during the implantation procedure without a cause correlated to a damaging action, there is a specific indication in the device instructions for use, under the paragraph 'viii.Directions for use' illustrating how to proceed to close the purse.This indication allows to use the device even if the blue thread breaks during the implanting procedure.However, based on this analysis the root cause of the event is unknown as the action that lead to the reported issue cannot be confirmed and no further information is available.

• Brand Name: MITROFLOW VALSALVA CONDUIT
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7693113
• MDR Text Key: 114139452
• Report Number: 3005687633-2018-00174
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: MVC030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention