MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

"[doctor] of (b)(6) hospital performed a mvr on (b)(6) 2017 with on-x mc25/33, sn(b)(4).[the doctor] sized the mitral annulus after removal of damaged valve in the mitral position, all sutures well in place.Rupture was found while the mc25/33 was insert into the annulus position.[doctor] performed repair in the rupture position, after that he used a st.Jude mechanical valve to complete the operation.The whole operation last for over 12 hours.Patient sent to icu and ecmo is employed to assist recovery.We were informed on 7th april afternoon about this and the used valve was collected back.The valve is kept in our (b)(6) office right now.[doctor] did not say this adverse event was valve-related, only requested for valve replacement," via email.

Manufacturer Narrative

According to the report: "[doctor] performed a mvr on 04/06/2017 with on-x mc25/33, sn(b)(4).[the doctor] sized the mitral annulus after removal of damaged valve in the mitral position, all sutures well in place.Rupture was found while the mc25/33 was insert into the annulus position.[doctor] performed repair in the rupture position, after that he used a st.Jude mechanical valve to complete the operation.The whole operation last for over 12 hours.Patient sent to icu and ecmo is employed to assist recovery.[doctor] did not say this adverse event was valve-related, only requested for valve replacement." the reported event involves an onxmc-25/33 with the serial number (b)(4).Correspondence was made with manufacturer, who confirmed with the doctor that the reported event was not valve related.However, in abundance of caution, reviews were performed on the available information.A manufacturing review was performed for the valve.It was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.No non-conformances or deviations were noted.A review was performed of the available information.Onxmc-25/33, serial number (b)(4) was implanted/explanted on (b)(6) 2017.Information provided states the on-x valve was being placed when a rupture of in-determined size was observed in the annulus by the surgeon.The valve was removed to repair the rupture and a non-on-x valve was subsequently placed instead.There was no complaint from the surgeon about the on-x valve.Explantation as a result of a complication is identified as a risk of mechanical valve replacement.In this case the complication is a rupture of the annulus while the on-x valve was being placed.However, the cause of the rupture is not identified.So there is not any basis to indicate a relationship between the rupture and the valve.No further action is warranted.

Event Description

"[doctor] performed a mvr on (b)(6) 2017 with on-x mc25/33, sn(b)(4).[the doctor] sized the mitral annulus after removal of damaged valve in the mitral position, all sutures well in place.Rupture was found while the mc25/33 was insert into the annulus position.[doctor] performed repair in the rupture position, after that he used a st.Jude mechanical valve to complete the operation.The whole operation last for over 12 hours.Patient sent to icu and ecmo is employed to assist recovery.[doctor] did not say this adverse event was valve-related, only requested for valve replacement," via email.

• Brand Name: ONX MITRAL CONFORM 25/33
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144
• MDR Report Key: 6553718
• MDR Text Key: 74741453
• Report Number: 1649833-2017-00047
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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
• Device Operator: Physician
• Device Expiration Date: 01/01/2020
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/10/2017
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 04/10/2017
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other