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

Model Number PED-400-20

Device Problem Break (1069)

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

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

The pipeline flex braid will not be returned for evaluation as it implanted in the patient and pushwire the pushwire is requested to be return.Upon receipt of the device, a supplemental report will be filed.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 pipeline tip broke after pipeline flex braid implanted.Two pipelines were successfully deployed but bleeding did not stop so internal carotid artery (ica) was sacrificed.The patient underwent embolization treatment for bleeding of a tumor ruptured during removal located in ica.The vessel was observed moderately tortuous.It was reported that longer device that did not deploy perfectly and required manipulation to deploy.During the final stages of deployment and retrieval of deployment system, the pipeline flex pushwire tip broke off from device and was left floating in ica at the proximal end of the deployed pipeline.The physician was able to successfully aspirate the tip out via the distal access support catheter.The physician still deployed the pipeline with success, removed broken tip, and was able to successfully deploy a second pipeline for additional flow reduction at injury site.There were no reports of patient injury in association with this event.

Manufacturer Narrative

H6: codes updated the pipeline flex pushwire returned without pipeline flex braid as implanted in the patient.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex pushwire appeared to be separated at the distal hypotube.Bends were found on the pushwire from the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.The broken end of the pusher was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis.Based on the analysis findings, the pipeline flex was confirmed to have pushwire separation.The pipeline flex pushwire was separated at the distal hypotube.Per the sem/eds results: "some of the fracture surfaces exhibit corrosion damage.The fracture features observed indicate a bending overload type failure mechanism." from the damages seen on pipeline flex pushwire (bending) 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 pushwire through the catheter against resistance.It is possible that the patient tortuous anatomy and lack of continuous flush with heparinized saline during procedure have contributed to the resistance during delivery issue.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

There was no pipeline flex braid returned with the devices as it was implanted in the patient.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.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.Bends were found on the pusher at 27.0cm, 92.0cm and 158.0cm from the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable length of the catheter were measured to be within specifications.The phenom 27 catheter tip and the marker band were examined; and no damages were found.The catheter body appeared to be accordioned from 3.5cm to 6.5cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was flushed with water and water exited out from the catheter tip.A minimal amount of blood observed inside of the catheter lumen.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel could pass through the catheter tip and hub with no issues; however, resistance was observed at the accordioned locations.No damage was found with the returned navien.No other anomalies were observed.The broken end of the pusher was sent out for sem/eds analysis.Based on the analysis findings, the pipeline flex was confirmed to have pushwire separation.The pipeline flex pushwire was separated at the distal hypotube.Per the sem/eds results: "some of the fracture surfaces exhibit corrosion damage.The fracture features observed indicate a bending overload type failure mechanism." in addition, per the core tech results: "flat, appears brittle, corrosion on fracture surface".From the damages seen on the phenom catheter body (accordioning), pipeline flex pusher (bending) 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 pushwire through the phenom catheter against resistance.It is possible that the patient tortuous anatomy and lack of continuous flush with heparinized saline during procedure have contributed to the resistance during delivery issue.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
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10071439
• MDR Text Key: 195392656
• Report Number: 2029214-2020-00467
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015937
• UDI-Public: 00847536015937
• 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,Followup
• Report Date: 09/26/2020

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: 03/12/2023
• Device Model Number: PED-400-20
• Device Catalogue Number: PED-400-20
• Device Lot Number: A991723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 05/26/2020; 09/08/2020
• Supplement Dates FDA Received: 06/08/2020; 09/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR