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

Model Number	PV-14-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rebar-18 micro catheter has a labeled id (inner diameter) of 0.021¿.Per the concerto ifu (instructions for use): concerto nylon detachable coils with diameters of 2mm to 4mm should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿.Therefore, the rebar-18 micro catheter was found to be compatible for use with the concerto coil.The concerto implant coil returned without the introducer sheath.The concerto implant coil pushwire was found to be bent at ~17.7cm, kinked at ~29.5cm and bent at ~98.7 from proximal end.The concerto implant coil was found to be stretched and damaged.The concerto coil could not be used for testing with the returned rebar-18 micro catheter due to its damaged condition.The concerto coils were returned for analysis with the rebar-18 micro catheter.The rebar-18 was found to be compatible with the concerto coils.However, the rebar-18 micro catheter could not be used for resistance testing due to its damaged condition.Therefore; any contributing factors (other than inner diameter specification) from the rebar-18 micro catheter could not be assessed.The concerto coil was returned without the introducer sheath.The concerto implant coil pushwire was found to bent.The concerto implant coil was found to be stretched and damaged.It is likely that the damage to the concerto implant coil and pushwire occurred during the attempt to push the coil through the micro catheter against the reported resistance.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the pv-14-30-helix was successfully inserted and advanced through the microcatheter under the instructions for use (ifu) procedure.However, before the coils came out from the distal lumen of the microcatheter for deployment, the surgeons felt a huge resistance in delivering the coil out of the microcatheter into the internal iliac artery.Hence, the surgeon directly pulled out the coil and tried the procedure again, but the delivery still failed.The device was replaced with a pv-12-30-helix where it was successfully inserted and advanced through the microcatheter under ifu procedure.However, before the coils came out from the distal lumen of the microcatheter for deployment, the surgeons again felt a huge resistance in delivering the coil out of the microcatheter into the internal iliac artery.Hence, the deployment failed.Also, the pv-12-30-helix could not be pulled out due to the resistance, and thus the coil was kept in the microcatheter the device was replaced with a pv-12-30-helix.It was noted that there was no damage with the either the catheters or coils.The patient was undergoing surgery for an embolization of the internal iliac artery in endovascular aneurysm repair (evar) treatment.It was noted that the vessel tortuosity was normal.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.Ancillary devices: 5 fr c1 guide catheter, rebar 18 microcatheter, 0.035 terumo guidewire.

• 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: 8531882
• Report Number: 2029214-2019-00366
• Device Sequence Number: 13933237
• Product Code: KRD
• UDI-Device Identifier: 00847536017016
• UDI-Public: 00847536017016
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K090046
• 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
• Report Date (Section B): 04/19/2019

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 Expiration Date: 05/18/2020
• Device Model Number: PV-14-30-HELIX
• Device Catalogue Number: PV-14-30-HELIX
• Device Lot Number: A463125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1