MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DS; LARGE FLEXNAV DELIVERY SYSTEM

Model Number FNAV-DS-LG

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, a 29mm portico valve was selected for implant using a large flexnav delivery system.The patient's perimeter was determined to be 79.1mm via computed tomography (ct) scan and the valve was sized according to the ifu.It was noted during procedure that the valve was too proximal during an initial deployment attempt.An attempt was made to res-sheath the valve.However, it was noted that the portico valve was unable to be recaptured.There were multiple attempts made to try fully recapture the portico valve back into the delivery system, but the valve for remained 40% deployed.It was observed via angiography that the delivery system was kinked.The decision was made to implant the 29mm portico valve in the descending aorta because it was the safest place to release without causing any damage.The delivery system was removed, and it was discovered that the valve capsule of the large flexnav delivery system was damaged.A second 29mm portico valve (18832400) was implanted in a valve in valve procedure with a replacement large flexnav delivery system.The patient remained hemodynamically stable throughout the procedure.The patient was in recovery at the time of the report.

Event Description

Subsequent to the previously fled report, additional information was received: it was reported that the patient did not have a tortuous anatomy.The patient's annular perimeter was 79.1mm and the portico valve had been sized using a computed tomography scan and according to the instruction for use (ifu).There was no initial or prolonged hospitalization as a result of this event.It is unknown what caused the damage to the valve capsule of the large flexnav delivery system.No additional information was provided.

Manufacturer Narrative

The reported event of a kinked delivery system was confirmed.Gross morphological examination revealed the valve capsule was creased and deformed.The returned state of the delivery system precluded using it for functional testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined, however is consistent with damage during use.

• Brand Name: FLEXNAV DS
• Type of Device: LARGE FLEXNAV DELIVERY SYSTEM
• 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: 15847269
• MDR Text Key: 307682206
• Report Number: 2135147-2022-02176
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 02/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: FNAV-DS-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 8334263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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