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

Model Number PED2-500-16

Device Problems Positioning Failure (1158); Material Deformation (2976); Activation Failure (3270)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the stent wouldn't open and it created a lip.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right internal carotid artery (rica) with an unknown max diameter and an unknown neck diameter.The patient's blood flow was unknown and vessel tortuosity was moderate.  it was reported that the phenom was brought into the m1 and the plan was to deploy the stent inside the m1.An unsheathing and resheathing occurred to make sure the ptfe sleeves were open.The unsheathing started and the stent opened distally and apposed vessel.The stent went further proximal than needed so the resheathing occurred.The stent came off the resheathing pad when resheathing.A second pipeline was brought up and the exact same event occurred.This time there was a large amount of built up stent when resheating and the stent disengaged from the resheathing pad.The physician still went ahead and deployed the stent even though they were aware the stent was disengaged from the resheathing pad.The stent was deployed and the proximal end wasn't fully apposed and created a lip.A third stent was brought up.The distal end wouldn't open after 5-6 attempts of repositioning and resheathing and pulling of the system with this stent.The stent had a failure to open at the distal end.The pipeline was not positioned in a bend.It was unknown if the pipeline was stuck in the capture coil.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than 2 times.No additional steps or other devices were required to open the pipeline.The pipeline was removed from the patient.The pipeline was resheathed and removed with the microcatheter. a dapt (dual antiplatelet treatment) was administered.It was unknown what the pru level was.The angiographic results post procedure were good.The stent was not fully apposed proximally, with a little lip.The pipeline and accessory devices were prepared as indicated in the ifu. there were no patient symptoms or complications associated with the event.    ancillary devices include a phenom 027.

Manufacturer Narrative

Patient information received.A4.Pt weight (80kg) b7.Updated, no relevant medical history.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

Product analysis: ¿ as found condition: the pipeline flex with shield pusher, phenom 27 catheter and penumbra catheter (non-medtronic) were returned within shipping box; and within a sealed plastic bio-pouch.¿ visual inspection/damage location details pipeline flex with shield pusher was returned stuck within phenom 27 catheter.In addition, the partial distal braid, sleeves and tip coil were deployed from phenom 27 catheter distal tip.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.The distal and proximal ends of the pipeline flex with shield braid was found to be fully opened and moderately frayed.No bent or kink were found with pusher.No defects were found with the tip coil, 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, marker band were examined; no damages were found.The catheter body was found to be accordioned from 4.7cm to ~1.5cm from distal tip.No flash or voids molded were observed in the hub.The penumbra catheter was found to be kinked at ~65.3cm from the hub.¿ testing/analysis: the pipeline flex with shield could not be pushed forward or removed.For further examination, the catheter was cut to remove the pipeline flex with shield pusher and braid from the catheter lumen.The phenom 27 catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.¿ conclusion: based on the analysis findings, the pipeline flex was not confirmed to have failure to open at the distal end.The event cause could not be determined as the distal and proximal ends of the pipeline flex braid appeared fully opened and moderately frayed.However, the cause for damage could not be determined.Possible cause for failure to open includes patient vessel tortuosity.However, based on analysis finding, the customer reports of "difficult placement/positioning" was confirmed as the returned pipeline flex shield was found to be stuck at the distal segment of the phenom catheter.The pipeline flex shield and the phenom catheter were damaged.From the damages seen on the catheter body (accordioning), 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 advance/retrieve the pip eline flex shield through the phenom catheter against resistance.It is likely that the moderate vessel tortuosity may have contributed to the resistance during delivery.Per our instructions for use (ifu): "discontinue delivery of the device if high force or exce ssive 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.¿ there was no non-conformance to specification that may have contributed to the failure to open 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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12584831
• MDR Text Key: 281514473
• Report Number: 2029214-2021-01245
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-16
• Device Catalogue Number: PED2-500-16
• Device Lot Number: A994684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG