MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number FG15150-0615-1S

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889)

Event Date 07/23/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received a report that two pipeline devices became stuck at the hub of the microcatheter.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the distal internal carotid artery with a max diameter of 4mm and a 5mm neck diameter.It was noted the patient's and vessel tortuosity was moderate.It was reported that the pipeline (pli-10) became stuck/locked up at the hub of the catheter during re-sheathing.A continuous flush had been administered, the physician released the slack in an attempt to resolve the issue, but the device was eventually removed.A second pipeline (pli-20) was prepared and experienced the same issue as the first pipeline.It was stated the patient's anatomy provided difficult access, and the system dropped back when deploying because the sofia was not supportive enough.There was no damage observed to the pipeline devices or microcatheter.Ancillary devices include a 5fr sofia, phenom 27.Additional information received reported devices were used for retrieval of pipeline into loop sheath for secondary deployment which is not indicated in the instructions for use (ifu).It was reported that after the pipeline jammed it detached in the proximal end of the microcatheter while attempting to recapture the device.This issue occurred twice, with both pipelines deploying in the microcatheter.The procedure was completed with a third pipeline; the doctor successfully compensated for drop back by providing more forward tension on the guide catheter.They started deployment more distal and dropped back.The pushwire was not rotated or pulled back at any time during the procedure.It was later reported that the patient had a hemorrhagic stroke and the procedure and the patient died on (b)(6) 2020.The cause of the stroke was currently unknown, but it was not believed to be related to the device issues re ported.

Manufacturer Narrative

The pipeline flex shield could not be pushed forward or removed.For further examination, the phenom 27 catheter was cut to remove the pipeline flex shield.The pipeline flex shield pushwire appeared to be intact.No separation was found.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 distal and proximal ends of the pipeline flex shield braid were found fully opened and frayed.Bends were found at 13.0cm to 25.0cm from the proximal end.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 phenom 27 catheter were measured to be within specifications.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be accordioned at 5.0cm to 16.5cm 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 tip and hub.The mandrel successfully passed through the catheter hub and tip; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the returned devices, the pipeline flex shield and phenom 27 catheter were confirmed to have ¿resistance during resheathin g¿ and ¿catheter resistance¿ issues.However, the pipeline flex shield was not confirmed to have "pushwire detached at proximal to the wire weld" issue as the pipeline flex shield pushwire was found intact.No separation was found.The returned pipeline flex shield was found stuck inside the phenom catheter.From the damages seen on the catheter (accordioning), pusher (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 advance the pipeline flex shield through the phenom catheter against the resistance.It is possible that the patient's vessel tortuosity and lack of continuous flush with heparinized saline during procedure may have contributed to the resistance during resheathing.There was no non-conformance to specifications identified that led to the resistance issue.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.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 intraluminal 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.

• Brand Name: CATHERA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10408633
• MDR Text Key: 202965967
• Report Number: 2029214-2020-00798
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (y/n): N
• PMA/PMN Number: K151638
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: JA20-019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other