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

Model Number FG15150-0615-1S

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Dysphasia (2195); Thrombosis/Thrombus (4440)

Event Date 03/29/2023

Event Type  Injury  

Event Description

Medtronic received a report that two pipelines failed to open in the distal section, pushwire damage occurred, and two phenom catheters encountered resistance and kink/damage.A thrombus formed during the procedure and the patient underwent an additional thrombectomy.The patient was undergoing intracranial aneurysm blood flow directing dense mesh stent implantation for treatment of multiple saccular, unruptured aneurysms in the left internal carotid artery ophthalmic artery segment with a max diameter of 2.75 mm x 1.52 mm and 2.81 mm x 3.26 mm and a 2.86 mm and 3.13 mm neck diameter.The landing zone was 3.6 mm distally and 5.0 mm proximally.The accessed vessel was the femoral artery with a diameter of 7 mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered.The pru level is unknown.The angiographic result post procedure was normal.It was reported that when the operator treated an intracranial aneurysm, it was difficult to deliver two independent pipeline's in the catheter after choosing a ped.After the stent was very difficult to deliver in place, the tip of the ped could not be opened and frizz occurred.Catheter damage and stent damage were suspected.The catheter and stent were subsequently replaced.  after replacement, the same situation occurred, the stent could not be opened at the same place (distal end of the stent).It was reported there was pushwire damage that occurred.It was reported there was a kink in the distal section.It is unknown if there was friction or difficulty.The pipeline was removed from the patient.For lot# b336235 it was unknown what type of damage occurred to the pushwire.For lot # b336235 there was friction or difficulty during delivery which was characterized as severe.The pipeline was removed from the patient.It was reported the pipeline stent was poorly opened, and thrombus occurred during the operation, and the thrombus blocked the distal blood vessel, and the thrombus removal operation was performed.It was reported there was catheter resistance in the middle of the catheter.For the phenom catheter with lot # 225150526 it was reported there was a catheter kink in the distal section.The pipeline was not used for an indication that is off-label.The pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.Ancillary devices include an 8f guide catheter.

Manufacturer Narrative

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 that the patient is in the hospital recovering well from the procedure.The patient had aphasia after waking up but it was relieved at present.Partial removal of the thrombus was achieved.The pipeline opened in the straight segment of the middle cerebral artery.It was noted that there was additional steps or other devices attempted to open the pipeline and the device was retrieved once as a whole and deployed the stent, the tip of the stent could not be opened at the same position.A medtronic rebar and bridge intracranial support catheter (silver snake) were also used for the procedure.

Manufacturer Narrative

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 #(b)(4): as found condition: the pipeline flex and phenom 27 catheter were returned inside of a sealed bio-hazard bag and a shipping box.¿ 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.The distal end of the braid appeared not opened due to damaged braid.The proximal end of the braid was found opened and frayed.No bend was observed on 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 was found to be accordioned at 7.4cm to 12.6cm from the distal tip.No other anomalies were observed.Testing/analysis: the pipeline flex could not be pushed forward or removed.The catheter was cut to remove the pipeline flex.The catheter total and usable length were measured within specifications.The catheter was flushed with water and found patent.The catheter was then tested by running an in-house 0.0260¿ 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 customer complaint were confirmed as the returned pipeline flex was stuck inside the phenom 27 catheter.In addition, the distal end of the braid was not opened due damaged braid.From the damages seen on the catheter (accordioning), braid (fraying), and hypotube (stretching); it appears there was high force used.It is possibly these damages occurred when the customer attempted to advance the pipeline flex through the catheter against resistance.However, the cause could not be determined.Possible cause of resistance includes lack of continuous flush during delivery.Possible cause of failure to open includes damaged braid.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: 16665039
• MDR Text Key: 312548651
• Report Number: 9612164-2023-01440
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 225150526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/06/2023; 06/23/2023
• Supplement Dates FDA Received: 04/10/2023; 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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 Outcome(s): Other