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

Model Number PED-325-20

Device Problem Break (1069)

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

Event Date 07/14/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that pipeline flex device stuck inside the medtronic catheter and distal part of the pushwire along with the pipeline got detached inside the catheter during removal. The patient was undergoing embolization treatment for a flow diversion of a small unruptured 2 blister aneurysm located in internal carotid artery (ica) bifurcation and middle cerebral artery (mca). Measuring 2. 5 mm x 2. 5mm, 2mm x 1. 5mm, neck diameter (mm) 2. 5mm, 1. 5mm. Landing zone distal 3mm proximal 3. 27mm. The vessel was observed severely tortuous. It was reported that left ica was accessed with guide sheath and medtronic distal access catheter. There was an acute bend in the cavernous segment and this was not an issue to take medtronic catheter and non-medtronic guidewire across and beyond aneurysm and to the distal landing zone. When pipeline flex device was tried to navigate to its target position, the physician felt hard to navigate beyond terminal ica. It was observed the device getting twisted and the physician decided not to proceed further and removed the device. While removing he observed the pipeline flex had got detached in the catheter itself. Another pipeline device and another medtronic catheter was used and completed the procedure successfully. The angiographic result post procedure shows stasis after second device deployed. There were no reports of patient injury in association with this event.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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 ; 7635263305
• MDR Report Key: 8809906
• MDR Text Key: 153123648
• Report Number: 2029214-2019-00763
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CE
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-325-20
• Device Lot Number: A395077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial