MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DS

Catalog Number UNK FLEXNAV DS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Renal Failure (2041); Perforation of Vessels (2135)

Event Date 03/14/2017

Event Type  Injury  

Event Description

Crd_1025 - portico valve-in-valve retrospective registry, patient site id: (b)(6).It was reported that on (b)(6) 2017, a 23mm portico valve was implanted into a patient using an unknown flexnav delivery system.During the procedure, after the device was implanted, the common iliac artery ruptured.The patient experienced transient hypotension and was administered metaraminol by iv.The iliac artery was repaired by covered stents.The patient was then given a packed red blood cells (prbc) transfusion.The patient had a prolonged hospital stay, and the event was declared resolved (b)(6) 2017.

Manufacturer Narrative

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

Manufacturer Narrative

An event of hypotension, pulmonary edema, and acute kidney injury after the implant procedure was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the available information, the root cause of the reported event of hematoma could not be conclusively determined.

Event Description

Subsequent to the previously filed report, additional information was received.Acute kidney injury (aki) was reported as a result of the common iliac artery injury.The patient was transfused 9 units of prbc.Post-procedure, pulmonary edema was observed.Patient administered creatinine.Post procedure patient required non-invasive ventilation and continuous positive airway pressure.No patient consequences were reported.

• 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: 16114752
• MDR Text Key: 306877417
• Report Number: 2135147-2023-00078
• Device Sequence Number: 1
• Product Code: NPT
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLEXNAV DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2023
• 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; Other; Hospitalization
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 68 KG