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

Model Number PED-475-25

Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981); Activation Failure (3270)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

No device return so no product analysis could be performed.The cause of the event was not determined.Mdrs related to this event: 2029214-2018-00606 and this report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a pflex (4.75 mm x 25 mm) and an unknown pipeline product failed to open during a procedure to address an unruptured fusiform aneurysm located in the internal carotid artery (ica) posterior communicating artery segment.It was confirmed that the pipeline device and its accessories were prepped according to their indications for use (ifu).It was reported that the health care provider (hcp) attempted to open/flower the pipeline device in the m1 segment multiple times, but the device would not open after unsheathing 2/3 of the device; greater than 50% of the device was deployed.The hcp then attempted to position the device in the ica, but it again would not open.The device was removed from the microcatheter and rhv, and it was noted that the proximal end of the device looked crimped; however, only the middle part of the product was placed in a bend.Another device of the same size was used and it also would not open.The same diagnostics/troubleshooting were performed on the replacement device.It was noted, however, that the replacement device appeared normal upon removal and was not crimped.A 4.5 mm x 25 mm pipeline device was then used and opened on the first attempt.It was confirmed that usage of the new size resulted in a good outcome.The patient's vessel tortuosity was noted as severe; however, 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.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7673442
• MDR Text Key: 114042284
• Report Number: 2029214-2018-00609
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-475-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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