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

Model Number FG15150-0615-1S

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problems Failure of Implant (1924); Muscular Rigidity (1968); Vasoconstriction (2126)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

Refer to manufacturer's report 2029214-2023-01940, 2029214-2023-01942, 2029214-2023-01943, and 2029214-2023-01941 for details pertaining to the reportable related 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

Medtronic received a report that since there was severe tortuosity, the physician faced a lot of resistance to push the pipeline.Initial distal deployment was planned in just below the internal carotid artery (ica) terminus.It was a straight segment but due to vessel being tortious, the physician could not get 1:1 response and the physician took the cat 5 and cerebase distally.Then the physician tried deploying by pushing the pusherwire at the distal part but it was not opened.The physician tried around 10-15mm of the device but it still never opened.There was severe spasm happening in proximally.After multiple attempts, the physician decided to take out the pipeline and the phenom 27.  a second pipeline was used and taken into the straight segment but failed to open distally.In 3d there was some stenosis in distal aneurysm neck but in 2d and vessel imaging it was clear and having 4mm dia so came to con clusion that 3d image has flow related artifacts.Tried to open the pipeline even after crossing the aneurysm neck but unfortunately the middle and proximal segments also did not open and they could not resheath the pipeline.So decided to try to resheath the device into the sleeve of the device.The pipeline got stuck in the hub of the phenom.A third pipeline was used and planned to open in the middle cerebral artery (mca) m1 segment but there was a lot of resistance and the physician felt the pusher wire might kink so they did not take the risk and the pipeline was tried to open above the ophthalmic but this time the device did not open at the distal end.They physician ended up removing the pipeline and the distal end did not open.After these many failures, the physician did not want to take any more risks so the procedure was abandoned.The pipeline was not positioned in a bend and the pipeline was deployed more than 50% of the pipeline was deployed when it failed to open.The pipeline was not used for an off-label use.The pipeline and any accessories were prepared as indicated in the instructions for use (ifu).    the patient was undergoing surgery for treatment of a saccular, unruptured right ica cavernous giant an aneurysm with a max diameter of 20mm and a 5mm neck diameter.The landing zone artery size measurements were 4.6mm distally and 5.6mm proximally.The access vessel was the right ica with a diameter of 4.6mm-5.6mm.It was noted the patient's vessel tortuosity was severe.The post procedure angiographic result was the same as the pre-procedure angiography.  ancillary devices include a cerebase sheath, cat5 guide catheter, phenom 27 microcatheter, synchro guidewire.

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.

Event Description

Additional information was received that 5 days afterwards surpass evolve 5x30 was deployed.

Manufacturer Narrative

Product analysis: as found condition: the phenom 27 catheter was returned for analysis withing shipping box; within an opened phenom 27 outer cartoon and inner pouche; and a dispenser coil.Damage location details: no flash or voids molded were observed in the hub.No damage was found with hub.No bent or kink was found with catheter body.The phenom 27 catheter tip and marker were examined; and no damages were found.No other anomalies were observed.Testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water exited out from the distal tip.An in-house mandrel was inserted into the phenom 27 micro catheter hub and catheter lumen without issues.Conclusion: based on the analysis findings, the phenom 27 catheter could not be confirmed to have resistance as no defect was found with the returned phenom 27 catheter.No resistance was observed during testing.It is possible the patient's "severe¿ vessel tortuosity contributed to 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.

• 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: 17873878
• MDR Text Key: 324960284
• Report Number: 2029214-2023-01944
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00763000399702
• UDI-Public: 00763000399702
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 226809382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 65 KG