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

Model Number APB-2-6-HX-ES

Device Problems Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/29/2020

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 first two coils (3*2, 2*8) were successfully filled into the aneurysm.During the filling of the third colil (2*6) the coil was stretched, and a stent was used to assist to make the coil go against the wall.The coil was implanted at the intended location, there was no medical or surgical intervention, and the pushwire was not damaged.There was no friction or difficulty during delivery noted, no detachment attempts were made, repositioning was performed three times, rotation was performed, and a continuous flush was administered.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of an amorphous, ruptured aneurysm of the middle cerebral artery (mca) with a max d iameter of 6 mm and a 3 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Ancillary devices include a termao sheath, johnson & johnson guidecatheter, medtronic microcatheter.Additional information received from the physician indicated that the coil was stretched.Then when it was prepared to be withdrawn it from the body, it detached.The implantation stayed in the body and could not be removed.

Event Description

Additional information received indicated the blood vessel was not considered to be curved, and the microcatheter had tension during the embolization which led to the premature detachment.

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

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 received indicated the cause of the coil premature detachment was determined, but no clarification was received at this time.Halfway in the embolization, the coil was detached and left in the blood vessel.Later, the surgeon used the ab stent to stick the coil to the wall of the blood vessel.

• Brand Name: AXIUM PRIME BRPL HLX
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11178257
• MDR Text Key: 227057872
• Report Number: 2029214-2021-00059
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536032194
• UDI-Public: 00847536032194
• Combination Product (y/n): N
• PMA/PMN Number: K081465
• 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: 02/10/2021

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: 10/02/2023
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: B095525
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/18/2021; 01/29/2021
• Supplement Dates FDA Received: 01/28/2021; 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR