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

Model Number PED-400-30

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

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

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the pipeline flex device did to open during the procedure and during retrieving in the catheter, pipeline pushwire broke.The patient underwent embolization treatment for medium unruptured saccular right internal carotid cavernous segment large aneurysm, measuring 15mmx7.5mm, landing zone distal 3.0mm, proximal 4.2mm.The vessel was normal tortuous.It was reported that when the pipeline flex device was released, the physician could not open in the middle segment.It was planned to retrieve it for adjustment but found that the resistance was large.When the physician wanted to release it once more, still couldn't open it.The physician could only continue to try to retrieve it with large force and then retrieved it into the medtronic microcatheter.At this time, it was found that the pipeline pushwire was broken and disconnected from the delivery system.There were not any patient symptoms or complications associated with this event.No patient injury was reported.Post procedure result - blood flow was unobstructed, contrast agent retention was observed in the aneurysm, and there was no overall vascular bleeding.

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 device appeared to be stuck at the distal segment of the catheter and it could not be pushed or removed.For further examination, the catheter was cut to remove the pipeline flex device.The distal and proximal dps restraints were found to be intact.The dps sleeves and tip coil were returned for analysis but got damaged during removal from the catheter.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The distal end of the pipeline flex braid was fully opened and no damages.The proximal end of the braid was fully opened and slightly frayed.The hypotube was found to be stretched.The pushwire was found to be separated at the distal hypotube.Corrosion was observed around the broken end.No bends on the pushwire.The broken end sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis.Based on the device analysis and reported information, the report of ¿failure open¿ could not be confirmed.The event cause for ¿¿failure open¿ could not be determined as the braid was found fully opened.Possible causes include the damaged braid and patient tortuous anatomy.Regarding to ¿pushwire separation¿ issues, the customer complaint was confirmed.The pipeline flex was found to be separated at the distal hypotube.Per the sem report, the fracture surface exhibits corrosion damage that obscured the original fracture features.Most of the fracture surface exhibited dimple features consistent with ductile overload failure.From the damages seen on pipeline flex braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the catheter against resistance; subsequently causing the pushwire to separate.It is likely that the lack of continuous flush during delivery may have contributed to the report.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: 9362436
• MDR Text Key: 186757738
• Report Number: 2029214-2019-01160
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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 Expiration Date: 04/18/2022
• Device Model Number: PED-400-30
• Device Lot Number: A817758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR