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

Model Number PED-500-30

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

Patient is between (b)(6) years old.If information is provided in the future, a supplemental report will be issued.

Event Description

Young rw, bender mt, colby gp, coon al.Multiple pipeline twists encountered during treatment of a symptomatic fusiform ica aneurysm.Bmj case reports.2019;12(7).Doi:10.1136/bcr-2019-230036 medtronic literature review found a report of pipeline embolization device (ped) ¿twisting¿ intra-operatively.This is a complication that manifests with the appearance of a ¿figure-8¿ in perpendicular planes on digital subtraction angiography.The purpose of this article was to present a case in which three unique ped implants became twisted during pipeline embolization of a large fusiform internal carotid artery aneurysm.The twists were remediated by balloon angioplasty and a combination of techniques that allowed the ped to rotate and restore its original axis.Six-month and twelve-month follow-up angiography demonstrated complete aneurysm occlusion with preservation of the parent vessel.The initial 4.75×30mm ped was opened in the middle cerebral artery and dragged back to the supraclinoid ica, covering a large non-fetal posterior communicating artery.Mid-deployment of the first device, a twist developed at the anterior genu which was remediated by wagging and stretching the device, then resheathing it with the via 27 microcatheter to milk the twist proximally along the braid.The ped was then deployed initially within the intermediate catheter and then within the parent vessel with excellent apposition.A second 5×30mm device was utilized and during its deployment a mid-device twist occurred again.This was remediated by moving the braid forward and backwards.A third ped device used for the construct (5×30mm) became twisted in two distinct places.The device could not be re-sheathed, so the proximal device was deployed into the intermediate catheter by unsheathing (as opposed to pushing) to prevent locking the twist in.The device was unsheathed from the intermediate catheter by engaging the proximal edge with the via27 catheter, allowing the twist to unfurl.The second twist was progressively opened by tracking the via through it over the delivery wire.The via was exchanged for a transform balloon and angioplasty facilitated untwisting.A fourth device was deployed in uncomplicated fashion to connect the construct to normal parent vessel proximally.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10974643
• MDR Text Key: 225572090
• Report Number: 2029214-2020-01262
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

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 Model Number: PED-500-30
• Device Catalogue Number: PED-500-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/09/2020
• 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