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

Model Number PED2-475-20

Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

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 stent which failed to open at the distal end during a procedure and then became stuck in the marksman catheter.The patient was being treated for an unruptured fusiform aneurysm of the left interior carotid artery.Dual antiplatelet treatment (dapt) was administered and pru level was 175.Patient vessel tortuosity was normal.It was reported that the catheter was navigated to the desired location.The physician started to deploy the pipeline but the distal end of the stent failed to open properly.The physician made multiple attempts to get the pipeline to open - resheathing and redeploying, removing tension in the system, but all without success.More than 50% of the stent was deployed when it failed to open.The device was resheathed less than or equal to 2 times.It was not positioned in a bend.While trying to resheath the pipeline, it beame stuck in the distal end of the marksman microcatheter.After this occurrence, the pipeline and marksman were removed together from the patient.Both devices were replaced and the procedure was then able to be completed successfully.All devices had been prepared and the catheter flushed per the instructions for use (ifu).There was no harm or injury to the patient.Post-procedure angiographic results were normal.

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 the pipeline became stuck inside the lumen of the marksman microcatheter.The pushwire was separated from the pipeline, and the distal portion of the marksman catheter was stretched.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the pipeline flex w/ shield (model: ped2-475-20 lot: a907491) and marksman micro catheter (model: fa-55150-1030 lot: 218807835) found that the marksman micro catheter total length was measured to be ~159.4 cm and the usable length was measured to be ~151.9 cm; which is within specification.The inner diameter was measured to be 0.027¿ which is within specification and compatible for use with the pipeline flex w/ shield.No flash or voids molded were found within the catheter hub.No damages or anomalies were found with the hub.The pipeline flex w/ shield braid was found within the hub.No damages or irregularities were found with the visible proximal end of the braid.The marksman micro catheter body was found kinked at ~17.8 cm from the proximal end and at ~15.6 cm, 8.9 cm and ~7.2 cm from the distal end.No damages or irregularities were found with the catheter distal tip or marker band.The micro catheter was flushed with water and water exited out from the catheter tip.Tweezers were used to remove the braid, damaging the proximal braid in the process.The distal braid was found damaged and frayed.The catheter was then tested by running an in-house 0.0260¿ mandrel through microcatheter.The mandrel passed through the catheter hub, catheter body and became stuck at the proximal kink when inserted proximally and at the distal kink when inserted into the distal end.When compared to the drawings.The hypotube was found stretched and ptfe shrink tubing was still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The distal delivery wire was found broken between the resheathing pad and the ptfe dps sleeves.The distal segment (dps sleeves, restraints and tip coil) was not returned for analysis.The broken end was sent out to element materials laboratory for sem testing.No other anomalies were observed.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed as the returned braid was found fully opened when removed from the marksman.One end of the braid was found damaged and frayed which could have caused the failure to open.Other possible causes for failure are patient vessel tortuosity, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.The customer report of ¿lockup/resistance at distal segment of catheter¿ and ¿catheter resistance¿ was confirmed.Resistance was encountered within the micro catheter at the kinked locations during in house testing.Possible causes for catheter kinking are patient vessel tortuosity, possible oversized od, pipeline removed aggressively, catheter entrapment or user advances/retrieves device against resistance.Customer report of ¿pushwire beak/separation¿ was confirmed.Sem test summary: the wire failed via torsional overload.Possible contributors towards pushwire breaks are patient vessel tortuosity, resistance during delivery/retrieval, over-manipulation, or user resheaths more than 2 times.There was no non-conformance to specifications identified that led to the reported issues.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10824098
• MDR Text Key: 217324297
• Report Number: 2029214-2020-01118
• 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: 02/08/2021

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: 09/30/2022
• Device Model Number: PED2-475-20
• Device Catalogue Number: PED2-475-20
• Device Lot Number: A907491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/12/2020; 01/28/2021
• Supplement Dates FDA Received: 11/26/2020; 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 74