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

Model Number PED-375-30

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline pushwire which broke during a procedure.The patient was being treated for an unruptured saccular aneurysm of the left internal carotid artery ophthalmic segment.The aneurysm max diameter was 3mm and the neck diameter was 2mm.Vessel tortuosity was moderate.It was unknown whether or not dual antiplatelet treatment (dapt) was administered.It was reported that all devices were prepared and used per the instructions for use (ifu).During the procedure, the position of the stent was to be adjusted after initial deployment.While retrieving the stent, the pushwire broke at the hypotube proximal to the wire weld.No friction or other difficulty had been encountered.It was not specified how many times the pushwire was rotated to deploy the stent.The broken segment of the pushwire was removed from the patient using the micro-guidewire and microcatheter.Stent assisted coil embolization was used to complete the procedure.There was no injury to the patient.

Event Description

Additional information received reported the pipeline was not implanted at the target position, it was ultimately implanted lower than the target position.It was noted that the device was implanted and would not be removed.

Manufacturer Narrative

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.

Event Description

Additional information received indicated no device or procedural images were available for review.The pushwire was sent back for analysis, but the stent was implanted in the patient and not removed.

Manufacturer Narrative

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.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the pipeline flex pushwire (lot no.A845212) found that the pushwire appeared to be separated into two segments.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 pushwire appeared to be separated at the distal hypotube.The pushwire was found to be bent at 24.0 cm to 56.0 cm 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 pushwire was sent out for sem and eds analyses.Based on the analysis findings, the pipeline flex was confirmed to have pushwire separation issue as the returned pipeline flex pushwire was separated at the distal hypotube.Per the sem/eds results: the fracture surfaces exhibit corrosion damage.The fracture features observed indicate a bending/twisting overload type failure.In addition, from the damages seen on the pushwire (bending) and hypotube (stretching); 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 catheter against the resistance.However, the cause for resistance could not be determined.Possible cause of resistance includes patient tortuous anatomy.Since the catheter was not returned; any contribution of the catheter to the resistance could not be determined.H6: method code updated to b01.Result code updated to c070601 and c070603.Conclusion code updated to d15.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: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10864130
• MDR Text Key: 217323638
• Report Number: 2029214-2020-01142
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015722
• UDI-Public: 00847536015722
• 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,Followup,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: PED-375-30
• Device Catalogue Number: PED-375-30
• Device Lot Number: A845212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 58