MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AAP UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number ONXAAP UNK

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

Patient Problems Anemia (1706); Bradycardia (1751); Hematoma (1884); Tachycardia (2095)

Event Date 07/19/2011

Event Type  Death  

Event Description

According to the initial report pertaining the onx-aap post-market clinical follow-up study, "here are another group of adverse events to report.I had a meeting with the site today and they assured me that obtaining additional information /records/source documents will not likely occur at this time.They provided what information they could obtain and if nothing was reported, it was because no further information was available to them." event #1 [(b)(6) 2011]: subject aap- 025 on day 2 from aortic valve replacement, anemia associated is documented on crf.Subject is documented to have received a transfusion.No source/medical records are included and details are unknown.Subject ultimately discharged from hospital setting on post op day 22.Event #2 [(b)(6) 2011]: subject aap- 025 experienced tachy-brady syndrome on day 18 from aortic valve replacement while still hospitalized in the immediate post operative phase.Subject underwent insertion of dual chamber permanent pacemaker on same day and was ultimately discharged from acute hospital on day 22 post valve replacement.No source or medical records were provided.Event #3 [(b)(6) 2019]: subject aap- 025 was presented to emergency room on day 3059 with acute massive right sided subdural hematoma.Crf 5 indicates this is a major bleeding event.Inr at time of presentation was measured at 3.3.Subject underwent emergency hematoma evacuation/craniotomy.Subject ultimately expired on day 5 of the event.No source or medical records were provided.While performing crf review, noted aes had been documented- no medical records have been provided for review.Reported available information to field assurance.No additional information forthcoming.

• Brand Name: ON-X AAP UNKNOWN CONFIGURATION
• 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 ; 7704193355
• MDR Report Key: 13843904
• MDR Text Key: 287579414
• Report Number: 1649833-2022-00007
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXAAP UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening