MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNK-NV-AXIUM

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The axium coil was returned with reference numbers indicating the device was related to this event and the coil is reported based on analysis results.However, no mention was made of any axium coil in the complaint information.Product analysis findings: an unknown axium coil was returned for evaluation inside the biohazard bag and a shipping box.There was no catheter returned with the coil.The implant coil was found detached from the pushwire.The coin appeared to be pulling back from the lumen stop.The implant coil was found to be damaged and stretched with the polypropylene filament not intact.The shield coil was present and intact.The pushwire was also found to be broken at the break indicator; retained by the release wire; indicative of manual detachment was attempted.No damage was found on the distal end of the release wire.The ai and coupler tubing was present and intact.In addition, bends were found at 17.0cm and 34.0cm from the proximal end of the pushwire.The detach element was in good shape and the detachment ball was measured to be 0.0038" and found to be within specifications.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.075mm @ 0.063mm; measured 0.087mm @ 0.127mm; measured 0.098mm @ 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 0.00260¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00463¿and found to be within specification.No other anomalies were observed.Based on the analysis performed, the unknown axium coil appeared to be detached from the pushwire.Based on the returned device, there was evidence of manual detachment attempt to detach the coil as the pusher was found to be broken at the manual detachment location and retained by the release wire; with the coin pulled back from the lumen stop.The pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.The returned implant coil was found damaged and stretched.In addition, the pushwire was bent at several locations.It is likely that these damages occurred when the customer attempted to advance the coil through the catheter against the resistance.However, the cause for resistance could not be determined.The lot number was not reported.Therefore, a device history record review could not be performed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that one coil became stuck during delivery, one coil could not be detached, and three coils were detached manually after being unable to detach with the instant detacher.The patient was undergoing treatment for varices.The patient¿s blood blow was high, and the vessel tortuosity was minimal.Patient medical history included alcoholism and encephalopathy.It was reported that the physician attempted to deliver the first coil through balloon.The versa 14x65 coil (pli 70) did not track through the balloon, and the physician retracted the coil successfully.It was believed that this was due to a sizing issue, and the balloon id was likely larger than 041.A number of legacy concerto coils were then delivered.Afterwards, the physician tried to use a versa coil again with a 4f cobra catheter.The versa 6x40 coil (pli 10) tracked well.The physician did not use the instant detacher and went straight to a manual break.The wire broke at the hbi and the internal filament broke, but the coil did not detach.The physician tried breaking at other points, but the coil still could not be detached.Five manual detachment attempts were made.The coil was withdrawn successfully.A verse 7x40 coil tracked well and detached using the instant detacher without issue.Two versa 7x40 coils (plis 20, 40) and one verse 6x20 coil (pli 30) could not be detached with the instant detacher but were able to be detached using the manual break method.Two attempts were made with the instant detacher for each of these three coils.It was believed that the problem may have been with the instant detacher.The procedure was finished successfully, and the patient was doing well.Occlusion of the shunt was achieved, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).

Event Description

Additional information was received.No axium coils were used in this case (conflicting to the previously reported products).They did not have the lot and item number available for the balloon used in the case.There were no issues prior to detachment and no push wire damage.

Manufacturer Narrative

Product analysis: ¿ as found condition: an unknown axium coil was returned for evaluation inside the biohazard bag and a shipping box.There was no catheter returned with the coil.¿ visual inspection/damage location details: the implant coil was found detached from the pushwire.The coin appeared to be pulling back from the lumen stop.The implant coil was found to be damaged and stretched with the polypropylene filament not intact.The shield coil was present and intact.The pushwire was also found to be broken at the break indicator; retained by the release wire; indicative of manual detachment was attempted.No damage was found on the distal end of the release wire.The ai and coupler tubing was present and intact.In addition, bends were found at 17.0cm and 34.0cm from the proximal end of the pushwire.¿ testing/analysis: the detach element was in good shape and the detachment ball was measured to be 0.0038" and found to be within s pecifications.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.075mm @ 0.063mm; measured 0.087mm @ 0.127mm; measured 0.098mm @ 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 0.00260¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00463¿and found to be within specification.No other anomalies were observed.¿ conclusion: based on the analysis performed, the unknown axium coil appeared to be detached from the pushwire.Based on the returned device, there was evidence of manual detachment attempt to detach the coil as the pusher was found to be broken at the manual detachment location and retained by the release wire; with the coin pulled back from the lumen stop.The pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.The returned implant coil was found damaged and stretched.In addition, the pushwire was bent at several locations.It is likely that these damages occurred when the customer attempted to advance the coil through the catheter against the resistance.However, the cause for resistance could not be determined.The lot number was not reported.Therefore, a device history record review could not be performed.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
• Type of Device: DEVICE, NEUROVASCULAR 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: 12110270
• MDR Text Key: 260496862
• Report Number: 2029214-2021-00813
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-AXIUM
• Device Catalogue Number: UNK-NV-AXIUM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 69 YR
• Patient Sex: Female