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

Model Number APB-2-4-HX-ES

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

See manufacturer report # 2029214-2022-01361 and 2029214-2022-01362 for other coils involved in this 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 three coils prematurely detached.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the right internal carotid artery siphon.The max diameter was 12.3mm, and the neck diameter was 8.3mm.The patient's blood flow was normal, and their vessel tortuosity was moderate.It was reported that there was a lot of resistance when the spring coil (fc-12-40-3d) was pushed from the protective sheath into the microcatheter.The surgeon withdrew the delivery guide wire and planned to take out part of the spring coil for observation.After the delivery guide wire was withdrawn from the microcatheter, it was found that it was detached and the coil body remained in the microcatheter.The coil was removed without further intervention.The pushwire was not bent/broken, the physician did not reposition the coil, no detachments had been made, and the delivery pusher was not rotated. during the process of filling the aneurysm with another spring coil (fc-8-20-3d), the surgeon tried to adjust the position of the spring coil into the loop.During adjustment, it was found that the spring coil was detached.At this time, part of the spring coil was still outside the aneurysm, which caused a greater risk of complications.The surgeon tried to use the capture device to take out the spring coil, but the spring coil stretched and broke during the process of taking out.Part of the coil body was left in the patient's body and part was taken out.No additional medical/surgical intervention was required. the pushwire was not bent/broken, there had been no friction/difficulty during delivery, no detachments had been made, and the delivery pusher was not rotated.The coil had been repositioned 2 times. when the surgeon adjusted the position of another spring coil (apb-2-4-hx-es) to the loop, it appeared detached.The coil was removed with the catheter without further medical/surgical intervention. the pushwire was not bent/broken, there had been no friction/difficulty during delivery, no detachments had been made, and the delivery pusher was not rotated.The coil had been repositioned once. a continuous flush had been administered the procedure. the devices were replaced, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).

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 during preparation the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

Manufacturer Narrative

H3: product analysis#: (b)(4): equipment used: video inspection system (m-85519) with microscope, ruler (m-83361), camera (panasonic lumix dmc-zs5) drawing(s) referenced: dwgs50566 rev.A; dwgs50520 rev.S; dwgs31195 rev.A; dwgs50523 rev.E as found condition: the axium coil and pushwire were returned within the inner pouch; inside of a biohazard bag and a shipping box., visual inspection/damage location details: the implant coil was found to be detached from the pushwire.The implant coil appeared to be damaged and stretched with the polypropylene filament intact.The shield coil found intact with no damage.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the distal break indicator (manual detachment location).The break indicator, ai and coupler tubing were missing and not returned.Testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.074mm @ 0.063mm; measured 0.086mm @ 0.127mm; measured 0.095mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop, and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00265¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00460¿and found to be within specification.The detached element was in good shape and the detachment ball was measured to be 0.0038" which was found to be within specifications.All other subassemblies appeared to be normal, and no other anomalies were observed.Conclusion: based on the analysis performed, the axium coil was confirmed to have "premature detachment" issue as the pushwire was returned with the implant coil already detached from the pushwire.The pushwire was found broken at the manual detachment location with the coin pulled back from the lumen stop.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.In addition, the returned implant coil was damaged.However, the cause could not be determined.There was no non-conformance to specification identified that led to the reported issue.Since the break indicator, ai and coupler tubing were not returned; any contribution of the break indicator, ai and coupler tubing to the reported issue could not be determined.Ls 2022-09-28 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
• 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: 15218022
• MDR Text Key: 297795043
• Report Number: 2029214-2022-01363
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536021006
• UDI-Public: 00847536021006
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APB-2-4-HX-ES
• Device Catalogue Number: APB-2-4-HX-ES
• Device Lot Number: 223429941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female