MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	PV-16-40-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the healthcare provider (hcp) wrote "defective - won't deploy" on the outside of the axium coil box.It was believed the coil would not detach, but the manufacturing representative (rep) did not have a clear understanding of what happened.There was no injury to the patient with the event.The patient was undergoing surgery for treatment of a splenic sac embolization.
Additional Manufacturer Narrative
H3: the concerto coil (model: pv-16-40-helix, lot: a998033) was returned for analysis.The pusher was found broken distal to the break indicator with the release wire was also found broken.The proximal segment (actuator interface, positive load indicator, break indicator and coupler tube) was not returned for analysis.This is usually indicative that a manual detachment was attempted at this location.The coin was found present and still against the lumen stop with the shield coil present and intact.The implant coil was still attached to the pusher.The implant coil was found stretched.A detachment was then attempted by breaking the pusher distal to the break and the release wire was pulled.The release wire did not retract and was stuck within the pusher.The distal outer jacket was removed, and dried blood was found within the jacket and lumen stop.The device was put into an ultrasonic cleaner to dissolve the dried blood.The release wire was then retracted, and the coin came out of the lumen stop, releasing the implant coil.No other damages or abnormalities were observed.Based on the analysis performed, the customer report of ¿non-detachment¿ was confirmed as the device was returned with the implant coil still attached.There was evidence of detachment attempt by breaking the break indicator.The likely cause of the non-detachment is the release wire broke during detachment attempt by the physician, leading to the release wire not retracting the coin out of the lumen stop and subsequently causing the implant coil to not detach.Possible causes for release wire break are damage during detachment attempt or resistance of the release wire.The dried blood found under the outer jacket and lumen stop contributed towards resistance.After the dried blood was dissolved, retracting the release wire successfully detached the implant coil.The implant coil was found stretched.Potential causes are patient vessel tortuosity, attempts to advance or retract device against resistance, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, incompatible catheter, or damage during return shipping to medtronic for analysis.There was no non-conformance to specification identified that could potentially contribute towards the non-detachment.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 PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10634594
• Report Number: 2029214-2020-01000
• Device Sequence Number: 2719580
• Product Code: KRD
• UDI-Device Identifier: 00847536033665
• UDI-Public: 00847536033665
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 03/24/2023
• Device Model Number: PV-16-40-HELIX
• Device Catalogue Number: PV-16-40-HELIX
• Device Lot Number: A998033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1