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

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.

• 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 Key: 12857205
• MDR Text Key: 281275743
• Report Number: 3007113487-2021-00082
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• 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 Number: PRT-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 Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/26/2021
• Supplement Dates FDA Received: 12/14/2021
• 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 Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 86 DA
• Patient Sex: Male