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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PORTICO NG VALVE, 35MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

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ST. JUDE MEDICAL, INC. PORTICO NG VALVE, 35MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PRT-NG-35
Device Problem Retraction Problem (1536)
Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967)
Event Date 11/03/2021
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2021, a 25mm navitor valve was selected for implant using a large flexnav delivery system.During procedure, the valve was deployed at 80%, however it was too high and needed to be re-sheathed, however it was "extremely difficult to re-sheath the valve." the valve was re-sheathed once, however not "all the way to the nose-cone." the valve was successfully implanted, however aortic dissection was reported.The patient was hemodynamically stable throughout the procedure.Post-procedure, while in the recovery room, the patient developed acute onset of delirium and transient right arm weakness.Stroke call was activated, however ct head was negative for acute vessel occlusion or hemorrhage; no treatment was required.In addition.The patient became hypotensive 90/50 and received medication.On (b)(6) 2021, increased troponin was observed, however no treatment was required.The patient was reported to be recovering.Clinical study patient id: (b)(6).
 
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
It was reported that on 3 november 2021, a 25mm navitor valve was selected for implant using a large flexnav delivery system.During procedure, the valve was deployed at 80%, however it was too high and needed to be re-sheathed, however it was "extremely difficult to re-sheath the valve." the valve was re-sheathed once, however not "all the way to the nose-cone." the valve was successfully implanted, however aortic dissection was reported.The patient was hemodynamically stable throughout the procedure.Post-procedure, while in the recovery room, the patient developed acute onset of delirium and transient right arm weakness.Stroke call was activated, however ct head was negative for acute vessel occlusion or hemorrhage; no treatment was required.In addition.The patient became hypotensive 90/50 and received medication, and the patient was diagnosed with hypercapnia.On 4 november 2021, increased troponin was observed, however no treatment was required.The patient was reported to be recovering.
 
Manufacturer Narrative
Additional information sections: b5, h6, h10.An event of difficulty in re-sheathing the valve during deployment and transient right arm weakness were reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
PORTICO NG VALVE, 35MM
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
177 east county road b
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
177 east county road b
st. paul MN 55117
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key12857205
MDR Text Key281275743
Report Number3007113487-2021-00082
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2021
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? Yes
Device Operator Health Professional
Device Model NumberPRT-NG-35
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/06/2021
Initial Date FDA Received11/22/2021
Supplement Dates Manufacturer Received11/26/2021
Supplement Dates FDA Received12/14/2021
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 Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age86 DA
Patient SexMale
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