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

Model Number PED2-500-30

Device Problems Break (1069); Activation Failure (3270)

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

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline failed to open distally and became stuck in the phenom 027 microcatheter upon retrieval.The patient was undergoing surgery for treatment of a fusiform, ruptured aneurysm with a max diameter of 5mm and a 5mm neck diameter and a landing zone of 3x5.15mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered and the pru level was prasugril 50 mg and aspirin 150 mg.It was reported that the pipeline didn't open distally, re-sheathing was attempted multiple times, and when retrieved, it got stuck in the proximal portion of the microcatheter.The catheter was flushed continuously with heparinized saline and the healthcare provider (hcp) released the load in the system in an attempt to resolve the issue, but the issue did not resolve.No damage was noted to the catheter or pushwire.Another device was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a phenom 027 microcatheter.

Manufacturer Narrative

G4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h6.Device codes - correction 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.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated as received, the pipeline flex with shield device was returned for evaluation and stuck within a medtronic catheter.The pipeline flex with shield pushwire was extending out of the proximal end of the catheter.The pipeline flex with shield device was then pushed out distally from the catheter with high resistance observed.Dried blood was observed on the tip coil, dps wings, and braid subassembly.The distal, middle and proximal braid did not fully open.During analysis, the distal inner wire became inadvertently separated from the hypotube at the solder joint.The braid was put into cleaning solution for 5 minutes to dissolve the coagulated blood.The entire braid subassembly fully opened once the dried blood started dissolving.Fraying and damage was found on the distal braid section.No damages or irregularities were found with the pipeline flex with shield pushwire, distal and proximal bumper, pad and dps wings.The hypotube was found intact with no stretching observed.Based on the analysis findings, the report of ¿failure/incomplete open distal (flex)¿ could not be confirmed as the braid fully opened after the dried blood was dissolved.There were no images submitted to review to confirm the failure to open.Potential causes for failure to open are: patient vessel tortuosity, damage braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, and inappropriate anatomy.The distal braid was found frayed/damaged which could contribute towards the incomplete open, however, it did not appear to contribute towards the issue during analysis.The pipeline flex with shield device was found stuck within the medtronic catheter.It is likely this is due to the damage to the braid and the dried blood found within the catheter and on the braid/pushwire.Other potential contributors towards resistance are patient vessel tortuosity, flush rate too low, catheter/device damage, insufficient catheter flushing or lack of continuous flush, insufficient delivery system hydration.Customer reported patient vessel tortuosity as moderate, all devices were prepared per ifu and pipeline was not placed within a bend.Customer reported multiple resheathing were attempted which may co ntribute towards the braid damage and subsequent resistance.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: 9574606
• MDR Text Key: 183127908
• Report Number: 2029214-2020-00025
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: A760977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1