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

Model Number APB-1-1-HX-ES

Device Problems Stretched (1601); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2021

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 axium coil experienced a little resistance during delivery, but when half of the coil entered the aneurysm, there was very large resistance.The physician decided to withdraw and readjust the position, but the coil was stretched in advance when they withdrew it a little.It was also noted the coil was detached and remained in the patient, but not at the intended location.There was no medical or surgical intervention required, and the pushwire was not bent or broken.There was no repositioning, rotation of the pushwire, or detachment attempts made.A continuous flush had not been used.After the stretch, the pushwire was withdrawn smoothly from the body and a stent was then added to ensure the safety of the patient.It was indicated that all devices were prepared as per the instructions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 a saccular, unruptured aneurysm of the left a1 section with a max diameter of 3 mm and a 1.5 mm neck diameter.It was noted the patient's blood flow was low and vessel tortuosity was moderate.

Manufacturer Narrative

B5.Amendment to initial reported information added.A4.Patient's weight information received and updated.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 there was a translation error in the initial report; the coil was detached but not stretched.

Manufacturer Narrative

H3: analysis of the axium coil (lot no.B109348) found that the implant coil appeared to be detached from the pushwire.The shield coil was found intact but stretched.The coin was not present against the lumen stop as it was pulling back.The pushwire was found to be broken at the break indicator; with the release wire pulling back; indicative that manual detachment was attempted at this location.Bends were found on the distal segment of the pushwire.In addition, the pushwire was found to be bent at 14.0 cm to 75.0 cm from the proximal end.The ai and coupler tubing were present and intact.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.080 mm @ 0.063 mm; measured 0.088 mm @ 0.127 mm; measured 0.097 mm @ 0.275 mm) 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 0.00462¿and found to be within specification.The sl-10 catheter appeared to be compatible for use with the axium prime coil as it has a labeled inner diameter (id) of 0.0165".All other subassemblies appeared to be normal.No other anomalies were observed.Based on the analysis performed, the axium prime coil was confirmed to have "coil resistance in catheter" and "premature detachment" issues as the pushwire was returned with the implant coil already detached.Bends were found on the pushwire.It is likely that these damages occurred when the customer attempted to advance the axium prime coil through the sl-10 catheter against the reported resistance.However, the cause for resistance could not be determined.Possible causes of resistance include the use of damaged catheter, patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.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.There was no non-conformance to specification identified that led to the non-detachment issue.H6: method code updated to b01.Result code updated to c0702, c070601, and c070603.Conclusion code updated to d15.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: 11515577
• MDR Text Key: 240646255
• Report Number: 2029214-2021-00302
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536032088
• UDI-Public: 00847536032088
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: APB-1-1-HX-ES
• Device Catalogue Number: APB-1-1-HX-ES
• Device Lot Number: B109348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 70