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

Model Number FG15150-0615-1S

Device Problems Difficult to Remove (1528); Stretched (1601); Deformation Due to Compressive Stress (2889); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

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

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that a phenom catheter had resistance in the distal portion causing the pipeline flex stent to migrate.The patient was being treated for an unruptured fusiform aneurysm in the left cerebellar location.It was a brain aneurysm embolization. the max diameter was 5mm and the neck diameter was 4mm.The distal landing zine was 2.25mm and the proximal landing zone was 3.20mm.Vessel tortuosity was moderate.The access vessel was the vaina shuttle and the diameter was 3.5mm the devices were prepared according to the instructions for use (ifu).  the stent was positioned correctly, with optimal distal opening at a 2.25mm segment, and optimal proximal opening.At the time of performing the recapture maneuver of the distal tip, the phenom microcatheter was advanced to the distal area and it was observed that the ptfe wings were not completely recaptured and when the phenom microcatheter was retracted it was noted that it pushed the device to the neck of the aneurysm that herniated in it, at that moment the system was withdrawn and another phenom microcatheter was used that was advanced inside the pipeline inside the aneurysm until it crossed distal to the m1 segment, then another pipeline device of 3.0 x 25 mm was implanted, what was it it was positioned distally and an optimal opening was made by telescoping the device that failed, without drawbacks and covering the neck of the aneurysm. the device migrated in its distal portion towards the neck and later into the aneurysm, this occurred because the push guide got stuck in the distal end of the microcatheter when trying to recapture the ptfe wings.The pipeline was implanted at the intended location.Full wall opposition was achieved.Side branches were not cove red by the pipeline as pushwire/capture coil stuck during retraction.The catheter was damaged.It was accordioned.The catheter was stretched in the distal section during removal.Force was applied during removal the catheter tip was stuck.There ws no vaso spasm.The pushwire was not damaged.A second pipeline was implemented to correct the fault.Dual antiplatelet treatment was administered. pru level prasugrel + aas.Angiographic result after the first implant: device with distal area inside the aneurysmal sac.Result after the second implant: devices covering the neck and wall correctly.No symptoms were reported.

Manufacturer Narrative

Refer to regulatory report# 2029214-2022-00265 for related information for the event.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 was received.The tip of the catheter was moved during deployment, according to the indications for use.The deployment technique included pushing the device and releasing tension on the microcatheter, it was noted at the moment of recapturing the distal tip of the pusher guide that the ptfe wings did not fully retract and they were positioned against the distal end of the pipeline.

Manufacturer Narrative

H3: the pipeline flex pushwire was returned stuck within the the phenom 27catheter; within the inner pouch; inside of a sealed bio-hazard bag and a shipping box.¿ visual inspection/damage location details: 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.Bends were found at 8.0cm to 31.0cm from the proximal end of the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be accordioned at 6.0cm to 13.0cm from the distal tip.No flash or voids molded were observed in the hub.No other anomalies were observed.¿ testing/analysis: the pipeline flex pushwire was pushed out from the catheter lumen with difficulty.The total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and found patent.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 with no issues; however, resistance was observed at the damaged locations.¿ conclusion: based on the returned devices, the complaint was confirmed as the returned pushwire was found stuck inside the phenom catheter.From the damages seen on the catheter (accordioning), pushwire (bending) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex shield through the phenom catheter against the resistance.However, the root cause could not be determined.Possible causes include patient's vessel tortuosity and lack of continuous flush with heparinized saline during procedure.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 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: CATHERA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 13582004
• MDR Text Key: 288989148
• Report Number: 2029214-2022-00266
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: AU21-010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 82 KG