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

Model Number PED2-475-25

Device Problems Positioning Failure (1158); Component or Accessory Incompatibility (2897); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the 1st pipeline (ped2-475-25) had problems opening up and had resistance during delivery.Additional information was required to determine the cause of the event.The hcp was contacted for clarification on the event and response was received.As the device had been disposed of, no analysis could be performed.There was no indication that the event was related to a potential manufacturing issue and no dhr was requested, so a device history record review was not performed.The ifu states: "do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis." placing the device on a bend may contribute to device having problems opening.¿caution: if high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously.Advancement of the pipeline¿ flex embolization device with shield technology against resistance may result in damage or patient injury.¿ the investigation determined that this was a known event, and therefore no new formal investigation was required.Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.Reference mdr# 2029214-2019-00560.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the first medtronic flow diverter (this reported device) did not open properly on the distal end and took a long time to open and a second medtronic flow diverter was implanted to telescope the distal end because they could not place the first pipeline at the precise location.The second flow diverter was also stated to not have opened correctly.The physician complained that both flow diverters were not visible on the screen of the siemens angiosuite.After the flow diverters were implanted, the inr did a post dilation to make sure the devices were completely open and also inserted more coils in the aneurysm.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of an unruptured amorphous aneurysm with a neck of 7mm located in the internal carotid artery (ica).The patient¿s vasculature was severe in tortuosity.Ancillary devices: microvention cosmos coils, terumo 16 guidewire, headway 27 microcatheter, fargo max 6f sheath.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: 8700818
• MDR Text Key: 148169465
• Report Number: 2029214-2019-00559
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2022
• Device Model Number: PED2-475-25
• Device Lot Number: A766245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/14/2019
• Date Device Manufactured: 01/14/2019
• 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
• Patient Age: 55 YR