MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number APB-1.5-2-HX-ES

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the axium prime coil prematurely detached after not being able to detach.The patient was undergoing treatment for two ruptured, amorphous aneurysms sandwiching the left internal carotid (ic) - anchor.The max diameter was 3.8mm, and the neck diameter was 3mm.The patient's blood flow and vessel tortuosity were normal.It was reported that the microcatheter was moved into the aneurysm with jailing technique to compress the distal aneurysm.Then the enterprise stent was half-deployed and the coil began to be compressed.However, the second coil could not be detached and it would not come off.Seven to eight attempts were made with the instant detacher, and three were made with the manual method.A second instant detacher was not used.The coil was collected, but it detached just after about 7mm was inserted into the catheter.The physician tried to use the guidewire to return the coil that overflowed in the catheter, but it did not work at all and the catheter was removed.The end of the coil that floated in the main tube was pressed against the vessel wall when the enterprise stent was implanted.The coil block was pulled when the catheter was removed, and the "ancho was destroyed", and it became a trouble afterwards.The third coil ended at the target. the devices were prepared according to the instructions for use (ifu).Ancillary devices include fubuki 6f guide catheter, phenom 17 microcatheter, and chikai 14 guidewire.

Event Description

Additional information was received on 2021-jul-28.It was not "destroyed", it was described as "crushed", which meant "blood vessel clogged".When the catheter was removed, the coil block was slightly deflected and blood flow to the anterior choroidal artery stopped.As far as it was seen at the site, there was no abnormality/kink/damage to the pushwire.The coil was not implanted in the intended location, it was partially deviated from the lump.Since the stent was supposed to be placed from the beginning, two enterprise were implanted and the deviated coil was pressed against the vessel wall.The blood flow to the anterior choroidal artery had stopped, so there might be some kind of problem, but the details remained unknown.

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

H3: an axium prime coil and an instant detacher were returned for analysis.The axium prime coil was returned without the introducer sheath.The actuator interface was found to be broken, not attached to the coupler tube but retained by release wire.There appeared to be evidence of mechanical detachment using an instant detacher at this location.There was no indication that a manual detachment was attempted.No bends or kinks were found with the rest of the pushwire.The coin was found not against the lumen stop.The shield coil was found intact with the implant coil already detached.The implant coil was no returned; therefore, any contributing factors could not be assessed.No other anomalies were observed.The distal outer jacket was removed, in order to gain access to the coin.The lumen stop and retainer ring were found to be visually in good condition.The coin was found to be visually acceptable.The lumen stop inner diameter was found to be occluded with blood; therefore, an accurate measurement could not be attained.The retainer ring was found visually acceptable, and the inner diameter was measured to be 0.0049¿, which within specification.No other anomalies were observed.Visual inspection of the assembled instant detacher (id) showed no defects.The surface around the bottom inner diameter of the instant detacher cap appeared to be clean.No other anomalies were observed.An in-house axium prime coil was then selected for testing with the instant detacher.No difficulty was experienced inserting the pushwire into the instant detacher, and the load indicator was not visible when the pushwire was fully seated in the instant detacher cap.The implant coil was successfully detached on the first attempt without any difficulty.During evaluation, the instant detacher was taken apart to evaluate the components.All components appeared to be normal.The instant detacher cap inner diameter was measured to be 0.0142¿ with visual inspection system.The instant detacher was found to be within specifications.Based on the analysis performed, the customer report of ¿premature detached from non-detachment¿ was confirmed as the axium pushwire was returned with the implant coil already detached from the pusher.The cause for the delayed detachment could not be determined as all parts of the returned pushwire which could affect the detachment were found to be within specifications.There was no non-conformance to specifications identified that led to the reported issue.Since the implant coil and detach element were not returned, any contributing factors could not be assessed.Customer reported vessel tortuosity was severe.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: AXIUM PRIME BRPL HLX
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12229863
• MDR Text Key: 264695144
• Report Number: 2029214-2021-00928
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536020948
• UDI-Public: 00847536020948
• Combination Product (y/n): N
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: APB-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: 220177894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Manufacturer Received: 07/17/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 07/28/2021; 10/08/2021
• Supplement Dates FDA Received: 08/20/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other