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

Model Number PED-400-10

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Fistula (1862); Foreign Body In Patient (2687)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis, as the stent and the proximal segment of the delivery system was left in the patient, and the proximal segment was kept by the treating facility.Since the device was not returned, we are unable to perform root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the pipeline flex implant was successful.However, the distal end of pipeline delivery wire broke and was left in the vessel.The proximal end of wire created an arteriovenous fistula (avf) into what the doctor believed to be the inferior petrosal vein with visible contrast filling into the vein upon injection into the ica.Challenging access due to proximal bend just past carotid bifurcation and two tight bends proximal to the aneurysm.First accessed using the navien and phenom catheter with a plan to use a pipeline flex 4.25x12.The doctor was unable to place the navien as far distal as he would have liked.When pushing the pipeline flex through the phenom around the tight bends proximal to the aneurysm the phenom catheter pulled back proximal to the aneurysm.The phenom and pipeline had to be removed without deployment.Access was reestablished using the sophia catheter and phenom with the sophia able to cross past the aneurysm for support.The 4x10 pipeline flex was advanced past the aneurysm and deployed.The pipeline was not fully apposed after deployment.When advancing the phenom back up over the pipeline delivery wire through the deployed pipeline it would not advance through the first turn before the pipeline.When the doctor went to adjust the pipeline delivery wire he realized that the wire had separated proximal to the first marker band.The proximal broken wire was removed and kept.The snare was then advanced up through the phenom but was not able to grab the proximal end of the broken wire.An attempt was also made to come from the left side across the acom to see if the distal end of the wire could be snared and removed through the left side, but the patient's acom was too small.Subsequent contrast runs into the right ica showed that the proximal wire tip had perforated the artery into the neighboring vein and contrast was visible in the vein.Patient was monitored and last contrast run was done with patient at a lower act level showing less contrast going into the vein.Plan is to monitor patient and possibly do a cta or another angio if needed.Broken wire goes from proximal to the pipeline to the ica terminus.Wire appeared to be stable with no movement.The pipeline and any accessory devices were prepared as indicated in the ifu.The separated device is in the distal ica from proximal to the pipeline placed to the ica terminus.Ancillary devices: cook shuttle sheath, navien.058 x 115cm subsequently switched out for a sophia 5fr 115cm catheter microcatheter, phenom.027 x 150cm, synchro 2 200cm, vascular solutions 4mm micro snare elite.Resistance was felt during advancement and during delivery.The resistance was moderate in severity.The patient was reported to be asymptomatic.Act at implantation was 411.The patient was on dual antiplatelet treatment.The aneurysm is in the right para-ophthalmic, right ica.The aneurysm was unruptured.The max diameter was 2.2mm with a neck of 3.4mm.The distal landing zone was 3.6mm and the proximal was 4.25mm.The vessel tortuosity was moderate.

Manufacturer Narrative

Updated sections: a1: patient identifier, a4: patient weight, 5b: patient race, b5: additional event details, b7: relevant history.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Medtronic received additional details: cta showed that the wire has not migrated and it does not show that blood is still leaking into the vein.The device will not be release at this time.The patient was reported to be home and doing well.Medwatch#: (b)(4) patient id (b)(6), female, 65 years, 136 pounds, white.Description: successful deployment of 4.00 mm x 10 mm pipeline embolization device in good position.Upon release of the device deployment section of the pushwire separated from the pusher ¿hypo¿ tube.Fragment was retained.

• 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
• MDR Report Key: 9503529
• MDR Text Key: 172428886
• Report Number: 2029214-2019-01274
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015784
• UDI-Public: 00847536015784
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: PED-400-10
• Device Lot Number: A826932
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 62