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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event was determined to be reportable based on analysis findings.Product analysis findings: as found condition: the concerto coil was returned for analysis within a shipping pouch; within an opened concerto outer carton (b112620) and within a plastic bio-pouch.Visual inspection/damage location details: upon visual inspection, no bends or kinks were found with the concerto pusher.The concerto coil was returned within its introducer sheath.The introducer sheath was found correctly assembled on the pusher with the wavelock at the proximal end.No damages were found with the introducer sheath.However, there was a presence of blood within the proximal and distal ends of the introducer sheath.Upon microscopic inspection, the implant coil was found broken from the pusher within the introducer sheath.The implant coil was found stretched with the polypropylene filament broken while within the introducer sheath.The proximal end of the implant coil appears to be jammed inside the introducer sheath ¿ testing/analysis: due to the damaged condition of the implant coil, it could not be removed from within the introducer sheath for further analysis.The concerto pusher was pulled out from within the introducer sheath.The concerto pusher was found bent 24.0cm from the distal end of the pusher.The implant coil was found to have broken off from the pusher from the coil shell weld.The inner diameter of the introducer sheath was measured to be 0.0185¿ (0.47mm) which is within specification (specification: 0.47mm +0.03 -0.00).¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.From the damages seen with the returned concerto coil (coil stretch/break) it appears excessive force was used.There were no reported issue preparing the concerto coil prior to use (which includes coil hydration).Therefore, it is likely that the implant coil became damaged during preparation or due to an improper hubbing technique (over tightening of the rhv).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the coil would not advance out of the introducer sheath.The patient was undergoing surgery to treat a gi bleed.It was noted the vessel tortuosity was normal.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.Additional information received reported that the introducer sheath was held at a slight angle when the implant coil was pulled back inside during hydration.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11852199
• Report Number: 2029214-2021-00602
• Device Sequence Number: 3792452
• Product Code: KRD
• UDI-Device Identifier: 00847536033481
• UDI-Public: 00847536033481
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/19/2021

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: 11/04/2023
• Device Model Number: NV-2-4-HELIX
• Device Catalogue Number: NV-2-4-HELIX
• Device Lot Number: B112620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1