MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS 23; HEART VALVE MECHANICAL

Model Number ONXAAP-23

Device Problem Device Handling Problem (3265)

Patient Problem Death (1802)

Event Date 07/07/2017

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 the initial report, "it was very difficult to remove valve handle from the valve.The physicians were concerned about pulling the handle off the valve.They open & wasted another conduit valve graft to see how the handle was to release.This handle would not release the same way.Difficult to remove valve conduit handle no harm done to patient." additional information received from patient care manager, (b)(6) 07/26/2017: "the case was during the night and i was not present.Looking through the chart, the patient was in the room at (b)(6).The patient is deceased.Please contact dr.(b)(6) regarding some the follow-up questions.".

Manufacturer Narrative

Follow-up information from the patient care manager indicated that ¿the patient is deceased.¿ the manufacturing records for the onxaap-23, 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.During the investigation no non-conformances or deviations were noted.A sample review was performed for the returned onxaap-23, sn (b)(4) on 09/08/2017 by visual examination.An aap holder handle from an onxaap-23, serial number (b)(4) was received 07/31/2017 with organic fluid residue (i.E.Patient¿s blood) and decontaminated for engineering investigation.Examination of the aap valve holder revealed severe markings caused by surgical instrument such as forceps or another type of medical instrument used inside surgical room.Plastic distortion texture suggests inappropriate high force applied on the surface of the valve holder.Apparent damage on valve holder caused repetitive load localized on pivot ridged by unknown surgical instrument.Such damage features uneven configuration, disabling the aap pivot from working properly.Under aap pivot, where ridged is located, reveals crushing damage with missing surface material caused by concentrated force of a metallic instrument.Examination of the right and left pivots side of valve holder revealed no apparent damage.Outer edge of the aap barrel displays small surface dentation caused by surgical instrument.Examination of the mechanism of the aap holder handle was tested by depressing the plunger to mimic resistance encountered by the physician during surgery.When plunger was completely depressed, valve holder was ¿sticking¿ sometimes at the imprinted stressed region featured by surgical instrument at the barrel edge.Could not fully test mechanical function because aap pivot ¿tab¿ was damaged previously.The holder handle was disassembled to examine the surface of each individual component and no physical anomaly was found.Inside the aap barrel surface was intact and undamaged.Examination of the aap spring and plunger did not display any manufacturing anomalies and it was undamaged.Analysis of the aap holder handle mechanical difficulty could not be studied because the damage introduced to the aap holder handle during surgery by some instrumental probing, manipulation or pressing on the valve holder.The stress levels found on the valve holder could have effectively compromised the aap holder handle structural integrity.The instructions for use (ifu) state ¿ the on-x ascending aortic prosthesis holder handle prosthesis is supplied on a plastic extended holder handle with spring action for one time use.This holder handle facilitates positioning the prosthesis during surgery.Warning: do not attempt to re-insert the holder handle into the prosthesis (valve) once it has been released from the prosthesis.Doing so could damage the valve and cause catastrophic failure of the valve or harm to the patient.A definitive root cause of the aap holder handle mechanical difficulty cannot be defined because specimen was significantly damaged in the field during surgery, prior to engineering evaluation.There is not enough information to establish what, if any, contribution the valve holder experience had to the death of the patient.This is most likely classified as a surgical death, although the patient's physiologic vitality may have been a significant factor as well.In any event, death is a recognized risk of complications associated with prosthetic valve replacement [instructions for use].If this is an operative mortality, and its proximity to the date of surgery would suggest as much, the american college of cardiology reports a rate for avr of 4% [edwards et al.2001].No further action is warranted at this time.

Event Description

According to the initial report, "it was very difficult to remove valve handle from the valve.The physicians were concerned about pulling the handle off the valve.They open & wasted another conduit valve graft to see how the handle was to release.This handle would not release the same way.Difficult to remove valve conduit handle no harm done to patient." additional information received from patient care manager, (b)(6)07/26/2017: "the case was during the night and i was not present.Looking through the chart, the patient was in the room at 2209- 1130.The patient is deceased.Please contact dr.(b)(6) regarding some the follow-up questions." additional attempts at correspondence have gone unmet.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS 23
• 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, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144
• MDR Report Key: 6818837
• MDR Text Key: 83605402
• Report Number: 1649833-2017-00063
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/26/2017
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death