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

Model Number	PV-14-30-HELIX
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
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, while advancing the coil into the support catheter after flushing, it became dislodged/detached in the catheter and straightened/stretched.As a result the physician removed the coil and replaced with that of another manufacturer.The patient was undergoing surgery for treatment of a bleed.It was noted that the vessel tortuosity was normal.The physician did not reposition/rotate the coil, nor did they attempt to detach the coil.A continuous flush was used throughout the procedure.There were no related patient symptoms.
Additional Manufacturer Narrative
The pusher is in one piece.Kinks and bends are present along the length of the pusher ~13.0 to 139.5cm from the proximal end.The ai to release wire crimps, coupler to ai crimps, and coupler to pusher tube weld are present and not intact.The pusher was broken at 25.5 cm from the proximal end from the proximal end; retained by the release wire; it appeared that the manual detachment was attempted.The coin was not present at the lumen stop as it was pulled back.The shield coil was present and stretched.The coil appeared to be detached from the pusher.In addition, the coil found to be damaged and stretched with the polypropylene filament broken.The detached element was not returned and missing from the proximal end of the coil.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and was found to be within specifications.Measured 0.070mm @ 0.063mm; measured 0.089mm @ 0.127mm; measured 0.093mm @ 0.275mm.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 (0.00220" minimum - 0.0029" maximum).The retainer ring inner diameter (id) was measured to be 0.00463¿and found to be within specificationrev.D.(0.00455"+/- 0.00010").All other subassemblies appeared to be normal.No other anomalies were observed.Based on the analysis performed the concerto coil was confirmed to have prematurely detached as the concerto coil was returned already detached from the pusher.There was no malfunction of the pusher or non-conformance to specification that may have contributed to the pre-mature detachment.Since the detached element and microcatheter were not returned, any contribution of the detached element or microcatheter to the issue could not be determined.Based on the event description it is was not possible to ascertain the cause of the pre-mature detachment; however, based on the returned device, there was evidence of mechanical and manual detachment attempts to detach the coil.The ai and twr crimps likely were broken during a mechanical detachment attempt.The pusher was also found to be broken 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.Furthermore, the pusher is bend and kinked along its length, indicative of high tortuosity.However, the customer reported that no attempts had been made to detach the coil and the patient vessel tortuosity was normal.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 or Problem Description
Medtronic received a report that, while advancing the coil into the support catheter after flushing, it became dislodged/detached in the catheter and straightened/stretched.As a result the physician removed the coil and replaced with that of another manufacturer.The devices were prepared and used per the instructions for use (ifu).The patient was undergoing surgery for treatment of a bleed.It was noted that the vessel tortuosity was normal.The physician did not reposition/rotate the coil, nor did they attempt to detach the coil.A continuous flush was used throughout the procedure.There were no related patient symptoms.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8165273
• Report Number: 2029214-2018-01068
• Device Sequence Number: 16634533
• Product Code: KRD
• UDI-Device Identifier: 00847536016996
• UDI-Public: 00847536016996
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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 Model Number: PV-14-30-HELIX
• Device Catalogue Number: PV-14-30-HELIX
• Device Lot Number: A469752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR