MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-500-18

Device Problems Difficult to Open or Close (2921); Material Deformation (2976); Activation Failure (3270)

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

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and evaluation is in progress.A follow-up mdr will be submitted when the investigation is complete.Suspect medical device brand name: pipeline flex with shield technology model number: ped2-500-18 mdrs related to this event: 2029214-2018-00620, 2029214-2018-00621.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the middle part of one pipeline embolization device (ped) and the proximal part of another ped of the same size did not fully open.It was confirmed that the device and all of its accessory devices were prepared according to their indications for use (ifu) and were not used for an indication that is not approved (off-label).The saccular aneurysm location was noted as "anterior circulation" and its status was "unruptured".It was reported that 50% of the middle section of a pipeline embolization device (ped) did not fully open as kinking occurred.The device was used with an unknown guide catheter, unknown microcatheter, and a phenom 27 guidewire.It was also noted that the proximal end of the device was placed in a bend and it was not suck in the capture coil.The product was resheathed twice and then redelivered, but the issue remained ongoing so it was replaced with another ped of the same size.The new ped opened at the distal and middle part, but not in the proximal part; the product was again replaced.There was no known impact or consequence to the patient.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The pipeline flex shield braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline flex shield braid appeared fully opened with moderately fraying at both ends.No other anomalies were observed.See related regulatory report 2029214-2018-00620.If information is provided in the future, a supplemental report will be issued.

Event Description

It is unknown if the second pipeline would have opened if the physician would have detached the device.It was noted that it looked like the proximal part was not going to open up so they did not detach it.The cause of the issue was unknown.The patient anatomy was not tortuous.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7688903
• MDR Text Key: 114558034
• Report Number: 2029214-2018-00621
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: A453449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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
• Patient Sequence Number: 1