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

Model Number PED2-500-20

Device Problem Activation Failure (3270)

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

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Refer to manufacturer report 2029214-2020-00992 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the original pipeline implanted required balloon angioplasty, but the distal end still failed to open.Two additional pipelines failed to open in the distal segments when used as intervention.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery with a max diameter of 4.57 mm and a 7.2 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown.It was reported that the patient was treated with a ped2-500-18 for a large cavernous carotid aneurysm.The vessel tortuosity was severe with evidence of stenosis in the distal landing zone of unclear origin.The first pipeline was very difficult to deploy and required post-op angioplasty which improved apposition at the proximal end but only mildly improved apposition at the distal end.Repeated attempts at angioplasty at the distal end were unsuccessful in achieving a fully opened pipeline.The procedure was completed, and the patient was sent to the intensive care unit (icu).The patient then awoke complaining of a headache, and angiography showed further narrowing of the distal end of the pipeline.The plan to deliver a coronary stent was unsuccessful as the vessel was too tortuous to deliver.Further balloon angioplasty was required, and then an attempt to deploy a 5x20 mm pipeline at the distal end was made.The technique used was to unsheath the distal segment and then transition to 80% push on the delivery wire.The distal end appeared to be stuck on the ptfe sleeves, and the doctor tried to resheath the device in order to push the sleeves out of the way.On further attempts at deployment, the distal end still did not open, and it appeared particularly flat on the inferior side.The doctor removed the pipeline through the microcatheter and noticed the distal tip was still closed once the pipeline was on the operating table.Another pipeline (5x10 mm) was then delivered without incident to the tip of the phenom microcatheter, and once again the distal end of the pipeline did not pen.A combination of unsheathing, pushing on the delivery wire, and loading and unloading the system was performed without success.The doctor managed to deliver the microcatheter and pipeline further distally into a straighter segment of the vessel, but this did not result in opening of the distal end.The doctor repeated the same exercises as he did in the proximal segment, but the pipeline still failed to open.The pipeline was removed from the patient.A solitaire ab (6 mm) was delivered and deployed with some improvement in the distal end of the original pipeline.It was noted the pipelines were in a bend: perfectly positioned in a u-shape around the carotid siphon.Post-procedure angiography showed the distal end of the original pipeline was still narrowed, but was improved with the solitaire ab in situ.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

H3: the pipeline flex w/ shield (model: ped2-500-20 lot: a994685) was returned for analysis.The pipeline flex w/ shield pusher was found bent at ~9.1cm from the distal end.The hypotube was found slightly stretched.No damages or irregularities were found with the resheathing pad, distal wire, dps sleeves, sleeve restraints, pad restraints or coil tip.The braid was already deployed.Both ends of the braid were found severely damaged and frayed.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 braid was severely damaged.These sorts of complaints usually cannot be confirmed during device.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents or inappropriate anatomy.Customer reported pipeline was placed in vessel bend, the vessel tortuosity was severe.The hypotube was found stretched and pusher was found bent, potentially caused by advancing/retracting against resistance.Possible causes for resistance are patient vessel tortuosity or device was not hydrated/continuous flush was not performed during event.The braid was found damaged/frayed.Possible causes are resheathing more than 2 times, high force delivery, over-manipulation or delivering/retracting delivery wire against resistance.Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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: 10624698
• MDR Text Key: 209804191
• Report Number: 2029214-2020-00993
• 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
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: A994685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR