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

Model Number APB-3-6-HX-ES

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/15/2021

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 coil was detached in the delivery system.It was noted there was no friction or difficulty during delivery, no coil repositioning, no pushwire rotation, no detachment attempts made, and no damage to the pushwire observed.A continuous flush had been administered during delivery.The coil remained in an unintended location in the patient, and a stent squeeze was used to secure the coil.A replacement product was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms were observed.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the anterior communicating (acom) artery with a max diameter of 4.8 mm and a 4.3 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.

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 reported that when adjusting the coil during the operation, it was found that it could not be withdrawn and was detached in the microcatheter.Since the coil was unable to be withdrawn, they continued to push it out of the microcatheter.

Manufacturer Narrative

H3: the axium prime coil was returned for analysis.The axium prime pusher actuator interface (ai) and hypotube break indicator (hbi) were found intact.No bends or kinks were found with the axium prime pusher.The axium prime pusher release wire coin was found against the lumen stop, the shield coil was found intact, and the implant coil was not still attached to the pusher.The implant coil was not returned.The release wire tip was found extending out of the distal end of the pusher for 0.002¿ which is within specification (specification:.003-.005¿).The release wire was pulled out of the pusher for evaluation of the coin.The release wire coin was found to be visually acceptable.The coin width was measured at 3 locations as per mp1526 and was found to be within specifications.The coin width was measured @ 0.063mm to be 0.082mm, @ 0.127mm to be 0.093mm, and @ 0.275mm to be 0.091mm (specification: @ 0.063mm: 0.063mm-0.089mm; @ 0.127mm: 0.075mm-0.105mm; @ 0.275mm: 0.086mm-0.108mm).The inner diameter of the lumen stop appears to be in good condition.The lumen stop id was measured to be 0.0023¿ which is within specification (specification: 0.00220-0.0029¿).The inner diameter of the retainer ring appears to be ovalized.The retainer ring inner diameter (id) was measured to be 0.0045¿ which is within specification (specification: 0.00455" ±.00010).Based on the device analysis and reported information, the customer¿s ¿premature detachment¿ report was confirmed.Premature detachment can occur due to tortuous anatomy, implant coil is not retracted in a one-to-one motion with the pusher during repositioning, pusher rotation, user advances the device against resistance, pusher damage, damage to retainer ring, retainer ring id above specification, or implant coil detachment ball outer diameter (od) below specification.The patient¿s vessel tortuosity was ¿normal¿, the axium prime coil was not repositioned, the pusher was not rotated, and no friction or other difficulty had been observed during delivery of the device.The retainer ring was found to be in good condition and the id within specification.The implant coil was not returned; therefore, analysis could not be performed and conformance to specification could not be assessed.Therefore, the root cause could not be determined.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: 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: 12032311
• MDR Text Key: 257179906
• Report Number: 2029214-2021-00746
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536032262
• UDI-Public: 00847536032262
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2023
• Device Model Number: APB-3-6-HX-ES
• Device Catalogue Number: APB-3-6-HX-ES
• Device Lot Number: B112632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 62