MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to initial reports, the "patient expired on table with onx valve implanted".Product will not be returned for evaluation.Onxmc-25/33 sn (b)(4) implanted (b)(6) 2019.The patient had rheumatic stenosis at the mitral position.The patient was obese but short.Patient bsa was around 1.6m2, per the surgeon, a bigger valve was used for better gradient.The patient was sent to the icu after the procedure.When the anesthesia was over she woke up with high pressure with systole at 180mmhg.The patient crashed and was sent to ot to be re-operated.However the patient expired soon after in the ot, the surgeon saw annulus rupture at postmortem.

Manufacturer Narrative

The manufacturing records for the onxmc-25/33 sn (b)(4) were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.A review of the available information was performed.Onxmc-25/33, sn (b)(4), implanted on (b)(6) 2019 with subsequent patient death the same day due to annulus rupture.According to the rep, "patient expired on table with onx valve implanted." additionally, it was reported, the patient had rheumatic stenosis at the mitral position.The patient was obese but short.The surgeon determined he should use 23mm instead of 25mm.Then he thought her bsa [body surface area] was around 1.6m2, hence a bigger valve will provide her better gradient.She was sent to the icu after the procedure, when the anesthesia was over, she woke up with high pressure with systole at 180mmhg.She soon crashed and sent to ot to be re operated.However, she expired soon after in the ot, the surgeon saw annulus rupture at postmortem.A definitive record of what the surgeon originally sized the annulus to be is unknown.However, used a 23mm instead of 25mm which suggests it may have been 23mm.Regardless, a larger 25mm valve was implanted as "he thought her bsa was around 1.6m2, hence a bigger valve will provide her better gradient." bsa, which is a measure of the individual's height and weight, is used as an index for annular dimensions of cardiac valves.There are studies to show the definite correlation between annular size and bsa.An accurate calculation of bsa can help confirm the correct valve size for the patient.The ideal valve size for a patient will provide the lowest transvalvular gradient possible - a larger valve size results in a lower gradient.Additionally, a valve size that is too small results in patient prosthesis mismatch.Although it was reported that "the patient was obese but short," 1.6m2 is the average bsa for an adult woman.However, we cannot confirm the age of the patient.Regardless, a larger size valve was implanted and ultimately the patient died due to annulus rupture.Additional information provided suggests that the surgeon acknowledges that they should have implanted the 23mm instead of the 25mm.The root cause for the patient death was annulus rupture and resulting hemodynamic collapse.Based on the available information, there are two possibilities that may explain the ultimate annulus rupture: implant of the 25mm valve was too large and ruptured the annulus tissue friability related to patient rheumatic heart disease resulted in annular rupture during implant.A definitive cause for the annulus rupture cannot be determined.Death is identified as a risk of mechanical valve replacement [instructions for use].The root cause for the patient death was annulus rupture and resulting hemodynamic collapse.Based on the available information, there are two possibilities that may explain the ultimate annulus rupture: implant of the 25mm valve was too large and ruptured the annulus tissue friability related to patient rheumatic heart disease resulted in annular rupture during implant.A definitive cause for the annulus rupture cannot be determined.No further action is warranted at this time.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to initial reports, the "patient expired on table with onx valve implanted." product will not be returned for evaluation.Onxmc-25/33 sn (b)(4) implanted (b)(6) 2019.The patient had rheumatic stenosis at the mitral position.The patient was obese but short.Patient bsa was around 1.6m2, per the surgeon, a bigger valve was used for better gradient.The patient was sent to the icu after the procedure.When the anesthesia was over she woke up with high pressure with systole at 180mmhg.The patient crashed and was sent to ot to be re-operated.However the patient expired soon after in the ot, the surgeon saw annulus rupture at postmortem.

• Brand Name: ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8675458
• MDR Text Key: 147214836
• Report Number: 1649833-2019-00036
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/31/2019
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death