MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO VERSA, DETACHABLE COIL; DEVICE, EMBOLIZATION, VASCULAR

Model Number	CV-8-40
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two versa coils (cv-7-40, lot #: b153515) and a third versa coil (cv-8-40, lot #: b153516) advanced through the microcatheter and deployed with no issues.The mechanical detacher was used with no success, and the manual detachment method also failed.Each of the coils were removed successfully.A cv-9-40 (lot #: b153517) was delivered and deployed with no issues, but failed to detach with the instant detacher and manual detachment methods.It was noted the wire broken during the manual detachment with this coil.A cv-5-30 (lot #: b154329) was advanced through the microcatheter and deployed with no issues.It was determined the coil was undersized for what was needed and removed.When used later, the coil became stuck at the distal end of the catheter and detached in the distal tip of the catheter.A cv-6-20 (lot #: b154962) coil was advanced through the microcatheter and deployed with no issues.It was determined the coil was undersized for what was needed and removed.When used later, the coil became stuck at the distal end of the catheter.When the instant detacher was used with a coil, the pushwire was seated in the hub of the instant detacher.The coil was detached successfully, and when the physician went to remove the wire, it was jammed and broke off.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.Refer to manufacturer report 2029214-2021-00354 for details pertaining to the related reportable event.
Additional Manufacturer Narrative
H3: the concerto versa coil was returned for evaluation.The implant coil appeared to be detached from the pushwire.The shield coil was present and intact.The coin was found pulling back from the lumen stop.No damage was found with the implant coil.Some of the coil fibers were observed to be flattened.No damage was found on the distal end of the release wire.The pushwire was found to be broken at the break indicator along with the positive load indicator, ai and coupler tubing appeared to be missing 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 (0.079mm @ 0.063mm; measured 0.088mm @ 0.127mm; measured 0.099mm @ 0.275mm) and found to be within specifications.The inner dia meter 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.All other subassemblies appeared to be normal.The catheter size and model were not reported; therefore, any contributing factors from the catheter including its compatibility for use with concerto versa coil could not be determined.No other anomalies were observed.Based on the analysis performed, the concerto versa coil was not confirmed to have "non-detachment" issue as the pushwire was returned with the implant coil already detached.The root cause could not be determined.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 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 that led to the non-detachment issue.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the break indicator, positive load indicator, ai and coupler tubing were not returned; any contribution of the break indicator, positive load indicator, ai and coupler tubing to the reported issue 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: CONCERTO VERSA, DETACHABLE COIL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11582610
• Report Number: 2029214-2021-00355
• Device Sequence Number: 4845795
• Product Code: KRD
• UDI-Device Identifier: 00763000321505
• UDI-Public: 00763000321505
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K202850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: 01/29/2024
• Device Model Number: CV-8-40
• Device Catalogue Number: CV-8-40
• Device Lot Number: B153516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1