MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DS

Model Number FNAV-DS-SM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 25mm navitor valve successfully implanted using an unknown flexnav delivery system, in a patient with previously diagnosed vascular disease.The vessel diameter of the patient was deemed acceptable for a right femoral approach.It was noted during procedure that there was one recapture of the 25mm navitor valve because of being deployed too high.It was noted that the navitor valve was implanted at a final non-coronary cusp depth of 4mm and the left coronary cusp depth of 5mm below the patient's annulus.The valve was successfully implanted and the delivery system was successfully removed.The patient had remained hemodynamically stable throughout the procedure.There was a noted trivial perivalvular leak around the navitor valve and the patient had a single digit gradient.It was noted during a radiographic examination of the patient's femoral that there was a minor vascular complication due the femoral dissection.The vascular complication was treated using an an unknown vascular balloon.A final digital angiogram of the vessel showed the dissection flap had been repaired and normal flow through the vessel had been resumed.The patient was sent to the catherization lab for recovery.It was noted that the patient was slow to wake up during recovery.A computed tomography brain scan was performed and discovered a calcium fragment in the anterior cerebral artery.The decision was made not to perform an embolic retrieval procedure.The patient was transferred to the stroke recovery unit to recover.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of dissection was reported.The patient's medical history included heart disease, stroke/tia and symptomatic aortic stenosis with increasing shortness of breath, and peripheral vascular disease.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.A returned device 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 but may be caused by cook's sheath.H6 health effect - clinical code: code 3160 removed.H6 health effect - impact code: code 4624 removed.H6 medical device problem code: code 2993 removed.

Event Description

It was reported that on (b)(6) 2022, a 25mm navitor valve successfully implanted using an unknown flexnav delivery system, in a patient with previously diagnosed vascular disease.The vessel diameter of the patient was deemed acceptable for a right femoral approach.It was noted during procedure that there was one recapture of the 25mm navitor valve because of being deployed too high.It was noted that the navitor valve was implanted at a final non-coronary cusp depth of 4mm and the left coronary cusp depth of 5mm below the patient's annulus.The valve was successfully implanted and the delivery system was successfully removed.The patient had remained hemodynamically stable throughout the procedure.There was a noted trivial perivalvular leak around the navitor valve and the patient had a single digit gradient.It was noted during a radiographic examination of the patient's femoral that there was a minor vascular complication due the femoral dissection.The vascular complication was treated using an unknown vascular balloon.A final digital angiogram of the vessel showed the dissection flap had been repaired and normal flow through the vessel had been resumed.The patient was sent to the catherization lab for recovery.It was noted that the patient was slow to wake up during recovery.A computed tomography brain scan was performed and discovered a calcium fragment in the anterior cerebral artery.The decision was made not to perform an embolic retrieval procedure.The patient was transferred to the stroke recovery unit to recover.Subsequent to the previously filed report, additional information was received.The dissection caused a delay in procedure.The 25mm navitor valve had been sized using 3-mensio computed tomography imaging.No hemodynamic compromised was reported.It was noted that a non-abbott sheath caused the vascular dissection.It was reported that the patient is deceased.The cause of death was a combination of stroke and the patient¿s comorbidities.The patient's date of death was (b)(6) 2022.It was noted that the 25mm navitor valve was functioning as intended prior to the patient's death.

• Brand Name: FLEXNAV DS
• Type of Device: FLEXNAV DS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15831365
• MDR Text Key: 303996004
• Report Number: 2135147-2022-02110
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: 05415067031372
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 8150297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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
• Patient Age: 77 YR
• Patient Sex: Female