MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number PED-375-20

Device Problem Break (1069)

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

Event Date 07/03/2020

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 a pipeline distal wire broke.The patient underwent embolization treatment for a small right ophthalmic aneurysm.The vessel was moderately tortuous.No procedure needed to remove tip it fracture as it came into micro catheter so it was totally housed within the microcatheter.The fracture occurred after ped was deployed successfully as delivery system was being recaptured within micro catheter.Everything is totally fine patient is doing great.

Manufacturer Narrative

No damages or irregularities were found with the pipeline flex proximal pusher.The pusher hypotube was found broken near the distal end of the hypotube with the ptfe shrink tubing damaged at that same location.No stretching was found with the hypotube.The distal broken segment was returned for analysis.No damages or irregularities were found with the tip coil, proximal bumper, resheathing pad, resheathing marker, dps sleeves, distal marker or distal wire.The broken end of the hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.Sem/eds summary: ¿most of the fracture surfaces exhibit corrosion damage that obscured the original fracture features¿.The catheter total length was measured to be ~158.0cm, the usable length was measured to be ~151.6cm and the distal single coil length was measured to be 14.6cm.As the model and lot number were not reported, conformation to specification could not be determined.No flash or voids molded were observed in the phenom-027 hub.No damages or irregularities were found with the catheter hub, distal tip or marker band.The catheter body was found kinked at ~0.5cm from the distal end.The inner diameter of the phenom-027 was measured via pin gauge to be 0.0270¿ (proximal) and 0.0270¿ (distal) which is within specification: 0.027¿ ± 0.001¿ and compatible for use with the pipeline flex device.An in-house 0.026¿ mandrel was then used for resistance testing.The mandrel was inserted through the catheter hub, through the catheter body and exited the catheter tip with no issues and no resistance encountered.No other an omalies were found.Based on the analysis findings, the customer report of ¿pushwire break at distal hypotube¿ was confirmed.It is possible the customer used high force when retracting the pusher causing the hypotube to break.The sem testing did not confirm an overload type failure due to corrosion obscuring the fracture features.See tr-nv12798 and capa2015-010156.Possible contributors towards failure are patient vessel tortuosity, catheter damage or user re-sheaths more than two times.Customer reported patient vessel tortuosity as moderate.The catheter kink could potentially cause resistance and lead to the hypotube break; however, no resistance was encountered during in house testing.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.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
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10311629
• MDR Text Key: 199990028
• Report Number: 2029214-2020-00715
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015661
• UDI-Public: 00847536015661
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2022
• Device Model Number: PED-375-20
• Device Catalogue Number: PED-375-20
• Device Lot Number: A859765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 10/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1