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

Model Number PED2-450-12

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 07/08/2020

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 that was damaged at the distal end and then detached within the phenom microcatheter during retrieval.The patient was being treated with flow diversion for an unruptured saccular aneurysm of a paraophthalmic artery.The aneurysm max diameter was 8mm and the neck diameter was 6mm.Patient vessel tortuosity was moderate.It was reported that the devices were prepare and the catheter flushed per the instructions for use (ifu).The microcatheter was navigated to the m1.The pipeline stent was being deployed using the drag and drop technique.When going through the bifurcation into the interior carotid artery (ica) the pipeline came out too quickly and was too close to the distal neck of the aneurysm.The surgeon resheathed the stent and navigated back to the middle cerebral artery (mca) to reattempt stent deployment.However, during the second attempt, the distal tip of the stent had a folded shape as if it had folded over on itself.Upon advisement from the manufacturer representative (rep) the surgeon resheathed the stent to remove and replace.When retrieving the stent back through the microcatheter, the stent detached from the pushwire and was stuck within the catheter so the system was all removed together.After removal, it was noted that the pipeline ptfe sleeves were missing from the deployment wire.Nothing could be seen remaining in the patient on angio.A second pipeline was deployed successfully with good vessel wall apposition.

Manufacturer Narrative

H3: the pipeline flex shield was returned stuck inside the phenom 27 catheter.The pipeline flex shield could not be pushed forward or removed.For further examination, the catheter was then cut to remove the pipeline flex shield.The pipeline flex shield pushwire appeared to be separated proximal to the dps sleeves.The tip coil appeared to be stretched and covered with dried blood.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact and fully opened with no signs of damage.The distal hypotube found to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex shield braid were found fully opened and frayed.Bends were found at 15.0 cm to 18.0cm from the proximal end of the pushwire.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip and marker band were examined; and no damages were found.The catheter body was found to be accordioned at 16.5cm to 27.5cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter hub and tip.The mandrel successfully passed through the hub and tip with no issues.However, the resistance was observed at the damaged locations.No other anomalies were observed.The broken end sent out for sem/eds analyses.Based on the analysis findings and sem/eds analysis, the pipeline flex shield and phenom catheter was confirmed to have ¿resistance during retrieval¿, ¿pushwire separation¿ and "catheter resistance" issues as the pipeline flex shield was stuck inside the phenom catheter.In addition, the pushwire was found to be separated proximal to the dps sleeves.The fracture surface exhibits dimple features consistent with torsional overload failure mechanism.In addition, from the damages seen on the catheter body (accordioning), pushwire (bending), pipeline flex shield braid (fraying) 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 shield through the phenom catheter against resistance.It is likely that the vessel tortuosity may have contributed to the resistance during retrieval; causing the pipeline flex shield pushwire to separate.There was no non-conformance to specifications identified that led to the resistance during retrieval and pushwire separation issues.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

On day two post-op, stenosis in the implanted second stent was noted.The surgeon successfully retrieved the clot.On day three, the patient's status was improving with only slight weakness remaining.The patient was treated with standard dual antiplatelet treatment (dapt).The surgeon did not believe the stenosis was related to the issues with the first stent.Additional information received reported there was no resistance during delivery.The resistance only occurred when the pipeline became stuck in the microcatheter during retrieval.The patient is currently in rehab with mild stroke symptoms on their left side.

Manufacturer Narrative

The stenosis and weakness with the second stent was previously reported in manufacturer report # 2029214-2020-00685.This device is not marketed or commercially distributed in the us, though it is similar to one that is.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: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10264742
• MDR Text Key: 200045452
• Report Number: 2029214-2020-00684
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284503
• UDI-Public: 00763000284503
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: PED2-450-12
• Device Catalogue Number: PED2-450-12
• Device Lot Number: B015324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1