MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-20

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event has not been returned for evaluation; therefore, the event cause could not be determined.Correspondence has been sent for the device and additional information.Once the device has been received and evaluation has been completed, a supplemental report will be submitted.Same event as mdrs: 2029214-2019-01190 2029214-2019-01191, 2029214-2019-01193, 2029214-2019-01194.If information is provided in the future, a supplemental report will be issued.

Event Description

2019-12-03 medtronic received information that the first pipeline flex (ped-500-20) would not open on the distal end.They attempted to resheath numerous times to push the flaps back so it was not covering the distal end, but it still would not open.Ultimately, they decided the pipeline was not going to open distally so they removed it from the patient.Then the physician went in with a phenom-27 and successfully deployed a new pipeline (ped-475-25).Upon attempting to recapture the delivery system with the phenom, the pipeline flex dislodged from its distal anchoring and the distal end of the pipeline flex was floating in the aneurysm.The physician re-wired and re-catheterized the outflow of the proximal end overlapping approximately 50% of the length of the pipeline flex (ped-475-25) deployed proximally.During the same procedure, two axium coils were implanted but has issues with detachment using the instant detacher (id).One coil finally detached with the id, while the other coil required use of the manual method (breaking of the hypo-tube, an alternative detachment method presented in the instructions for use).This was attempted 2 ¿ 3 times before the coil detached.Post procedural angiography showed that all vessels appeared intact and the two deployed pipelines and coils all looked technically placed successfully.The patient was brought back in that evening for stroke like symptoms.There was nothing seen on angiography at that time.It was noted that the pipeline was placed on a bend when it failed to open.The patient¿s vasculature was moderate to severe in tortuosity the patient was undergoing pipeline embolization with concomitant coiling treatment of an aneurysm measuring 4.32mm, 4.1mm proximal, 3.1mm+ distal, 9.77mm neck.It was located in the supraclinoid segment of the left internal carotid artery (ica).Prior to the coil non-detachment, there were no issues encountered and no damages were observed on the pushwire after removal form the patient.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9412361
• MDR Text Key: 208996563
• Report Number: 2029214-2019-01192
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: PED-500-20
• Device Lot Number: A843372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2019
• Date Device Manufactured: 06/06/2019
• 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