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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYRX, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC

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TYRX, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TYRX-AAE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Atrial Fibrillation (1729); Myocardial Infarction (1969); Septic Shock (2068); Heart Failure/Congestive Heart Failure (4446)
Event Date 08/26/2021
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: 407652 lead, 693565 lead implanted: (b)(6) 2014. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient is deceased. Approximately five weeks post implant, the patient was admitted to the coronary care unit with decompensated heart failure that was felt to be associated with rapid atrial fibrillation. During the hospitalization the patient was treated with anticoagulation, diuretics, beta blockers and anti-arrhythmic medications. An echocardiogram noted abnormal severe dilated left ventricle with reduced contractility. It was also reported that effective cardiac resynchronization therapy pacing was less than 90 percent of the time. An angiogram was performed and was normal. Approximately three weeks after admission, the patient was transferred to the intensive care unit with cardiogenic shock and septic shock and died three days later. The cause of death was noted as: septic shock with contributing cause of death of cardiogenic shock as well as an additional diagnosis of myocardial infarction. The patient is a participant in a clinical study.
 
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Brand NameTYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
Manufacturer (Section G)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13079371
MDR Text Key282731651
Report Number3005619263-2021-00039
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/07/2022
Device Model NumberTYRX-AAE
Device Catalogue NumberTYRX-AAE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/23/2021 Patient Sequence Number: 1
Treatment
DTMA2Q1 CRT-D, 439888 LEAD
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