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

Model Number PED-350-12

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned; however, the investigation has not been completed yet.Once the investigation has been completed, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that resistance was felt when retracting the medtronic flow diverter pushwire.Prior to the event, the flow diverter had been successfully implanted.It was during retracting of the pushwire inside the microcatheter in the right common iliac artery region that the reported event occurred.The physician continued to pull the pushwire against a lot of resistance and broke the proximal end of the pushwire inside the microcatheter.The tip was removed with the microcatheter.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of a ruptured saccular aneurysm measuring 6mm x 3mm located in the left internal carotid artery (ica).The distal and proximal landing zone was 3.2mm x 3.8mm.The vasculature was normal in tortuosity.The patient was on dual antiplatelet therapy and there are no images for review.

Event Description

Medtronic received information that resistance was felt when retracting the pipeline pushwire.Prior to the event, the pipeline had been successfully implanted.It was during retracting of the pushwire inside the phenom 27 in the right common iliac artery regionthat the reported event occurred.The physician continued to pull the pushwire against a lot of resistance and broke the proximal end of the pushwire inside the microcatheter.They tip was removed with the microcatheter.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of a ruptured saccular aneurysm measuring 6mm x 3mm located in the left internal carotid artery (ica).The distal and proximal landing zone was 3.2mm x 3.8mm.The vasculature was normal in tortuosity.The patient was on dual antiplatelet therapy and there are no images for review.Ancillary device: microvention traxcess 14 guidewire, medtronic phenom 27 microcatheter, phenom plus guide catheter, prenumbra neuron max 6f sheath.

Manufacturer Narrative

Device available for evaluation.Codes updated the device was returned for evaluation and the clinical observation was confirmed.The pipeline flex device returned without pipeline flex braid.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured within specifications.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex pusher appeared to be separated at the distal hypotube.Kinks and bends were found on the pusher at 22.5cm to 36.0cm from the proximal end.The broken end of the pusher was sent out for scanning electron microscope (sem) analysis.Based on the analysis findings and sem result, pipeline flex pushwire was found to be separated at the distal hypotube.The fracture surface features of the broken end are consistent with tensile overload.In addition, the pipeline flex pushwire was damaged.From the damages seen on the pipeline flex pusher (kinking/bending/ separating) and hypotube (stretching and separating); it appears there was high force used.It is likely these damages occurred when the customer attempted to retrieve the pipeline flex pushwire through the medtronic catheter against resistance.In this event, the user error may have contributed as the customer "continued to pull the pushwire against a lot of resistance and broke the pushwire inside t he microcatheter".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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8725558
• MDR Text Key: 149357072
• Report Number: 2029214-2019-00598
• Device Sequence Number: 1
• Product Code: OUT
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: PED-350-12
• Device Lot Number: A794030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR