MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-22-50-3D
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information reporting that an axium coil that had resistance in the microcatheter and could not be pushed out.The coil was replaced to continue the procedure. there was no harm or injury to the patient who was undergoing a coil embolization procedure to treat a grade 3 arteriovenous malformation.The abnormality was not located in the eloquent region.Blood flow was high.Additional information received reported the resistance was noted with the axium coil in the middle segment of the echelon microcatheter.The coil pushed out of the introducer sheath smoothly.After removal, it was noted the coil was kinked/damaged.On 2022-feb-14 (b)(4) (for, hcp, rep): additional information received reported the coil was stuck in the microcatheter and could not be pulled out, and the microcatheter was damaged at the tip end.
Additional Manufacturer Narrative
Device evaluated by mfr: product analysis #278729267: equipment used: video inspection system (m-78210), ruler 200cm (m-83361).Drawing(s) referenced: n/a.As found condition: the axium prime pushier was returned for analysis within a shipping box; within a plastic pouch.The echelon-10 micro catheter used in this event was not returned.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017.Per the axium prime coil ifu (instructions for use): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands¿ therefore, the echelon-10 micro catheter was found compatible for use with the axium prime coil.Visual inspection/damage location details: the axium prime pushwire was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium prime pushwire was found to be bent at ~68.7cm from proximal end.In addition, the axium prime pushwire was appeared to be bent within introducer sheath at ~133.54cm from proximal end.The axium prime implant coil was found to be detached/ broken from pushwire and not returned for analysis.Therefore, any contributing factors could not be assessed.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.Testing/analysis: the axium prime pushier was unable to pushed out from introducer sheath as it was found to be stuck.Due to its damaged condition, the axium prime pushwire could not be used for resistance testing with an in-house micro catheter.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ and ¿coil kink/damage¿ were confirmed and the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use, damage/kink to pushwire and lack of continuous flush during delivery.The axium prime implant coil was found to be detached and the pushwire was found bent.It is likely that the damage to the axium prime implant coil and pushwire occurred during the attempt to push the coil through the micro catheter against the reported resistance.Information regarding if a continuous flush was used, tortuous anatomy, failure to hydrate the axium prime coil prior to use were not provided.Therefore, any contributing factors could not be assessed and the cause for the event could not be determined.Since the echelon-10 micro catheter used in the event was not returned, any contribution of the micro catheter towards the ¿coil resistance/stuck in catheter¿ could not be assessed.The echelon-10 micro catheter was found compatible for use with the axium prime coil.(b)(4) 2022).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.
Additional Manufacturer Narrative
H3: product analysis #(b)(4):equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿ drawing(s) referenced: n/a ¿ as found condition: the axium prime pushier was returned for analysis within a shipping box; within a plastic pouch.The echelon-10 micro catheter used in this event was not returned.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017.Per the axium prime coil ifu (instructions for use): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands¿ therefore, the echelon-10 micro catheter was found compatible for use with the axium prime coil.¿ visual inspection/damage location details: the axium prime pushwire was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium prime pushwire was found to be bent at ~68.7cm from proximal end.In addition, the axium prime pushwire was appeared to be bent within introducer sheath at ~133.54cm from proximal end.The axium prime implant coil was found to be detached/ broken from pushwire and not returned for analysis.Therefore, any contributing factors could not be assessed.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.¿testing/analysis: the axium prime pushier was unable to pushed out from introducer sheath as it was found to be stuck.Due to its damaged condition, the axium prime pushwire could not be used for resistance testing with an in-house micro catheter.¿conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ and ¿coil kink/damage¿ were confirmed and the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use, damage/kink to pushwire and lack of continuous flush during delivery.The axium prime implant coil was found to be detached and the pushwire was found bent.It is likely that the damage to the axium prime implant coil and pushwire occurred during the attempt to push the coil through the micro catheter against the reported resistance.Information regarding if a continuous flush was used, tortuous anatomy, failure to hydrate the axium prime coil prior to use were not provided.Therefore, any contributing factors could not be assessed and the cause for the event could not be determined.Since the echelon-10 micro catheter used in the event was not returned, any contribution of the micro catheter towards the ¿coil resistance/stuck in catheter¿ could not be assessed.The echelon-10 micro catheter was found compatible for use with the axium prime coil.(nikkhs2 2022-07-24) 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 3D
• Common Device Name: 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: 15156952
• Report Number: 2029214-2022-01294
• Device Sequence Number: 12064175
• Product Code: KRD
• UDI-Device Identifier: 00847536030213
• UDI-Public: 00847536030213
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2024
• Device Model Number: QC-22-50-3D
• Device Catalogue Number: QC-22-50-3D
• Device Lot Number: B215586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female