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

Model Number	PV-4-12-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No damages or irregularities were found with the concerto pusher.The implant coil was found broken from the detach element with the polypropylene filament also broken.The broken implant coil was not returned for analysis.The concerto implant coil could not be used for resistance testing due to its damaged condition.No damages or irregularities were found with the stc-18 micro catheter hub.The stc-18 catheter body was found kinked at ~29.6cm, and found flattened at ~4.2cm from the distal end.The stc-18 has an inner diameter of 0.021¿ (per boston scientific website) which is compatible for use with the concerto coil.An in-house axium prime (model: apb-4-6-hx-ss lot: a280237) was then used for resistance testing.The coil was inserted into the catheter hub, through the lumen and out the distal end with no resistance encountered.All other subassemblies appeared to be normal and no other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be co nfirmed and the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to severely tortuous patient anatomy, failure to hydrate the concerto coil prior to use and lack of continuous flush during delivery.Customer reported vessel tortuosity as moderate.It is possible that the kink and the flattened section of the catheter contributed towards the resistance, however, the cause of the damage could not be determined.The implant coil was found broken.It is likely the implant coil became broken when attempting to advance/retract the device against the reported resistance.Other possible causes of implant coil break are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, or incompatible catheter.As the implant coil was not returned for analysis, any contribution of the implant coil towards the resistance could not be determined.There is no indication that the event is related to a manufacturing issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the concerto coil met resistance in the distal end of the renegade stc 18 microcatheter.The coil was replaced with another medtronic device to complete the procedure.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of an unruptured saccular aneurysm measuring 15mm x 8mm located in the splenic artery.The blood flow was normal, and the vasculature was moderate.There are no images for review.There was no damaged observed on the microcatheter or the coil.

• 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: 10589075
• Report Number: 2029214-2020-00970
• Device Sequence Number: 2977373
• Product Code: KRD
• UDI-Device Identifier: 00847536033764
• UDI-Public: 00847536033764
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• 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
• Report Date (Section B): 09/25/2020

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: 08/21/2022
• Device Model Number: PV-4-12-3D
• Device Catalogue Number: PV-4-12-3D
• Device Lot Number: A887049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1