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

Model Number	PV-6-20-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A concerto implant coil was returned for analysis within a shipping box; within an opened concerto implant coil inner pouch and within a dispenser track.Visual inspection/damage location details: the concerto implant coil returned out of introducer sheath.The concerto coil pushwire was found to be bent at 68.4cm, at 115.8cm, kinked at 140.9cm and at 187.2cm from proximal end.The implant coil was found to be broken and found within introducer sheath.The concerto coil could not be pushed out further from the introducer sheath for further evaluation as it was found to be stuck.The implant coil was found to be stretched and damaged within introducer sheath.The concerto coil tip od (outer diameter) was unable to be measured as it was stuck within introducer sheath.The id (inner diameter) of the introducer sheath was measured to be 0.0185in which was found to be within specifications.No other anomalies were observed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.However, the root cause could not be determined.There were no reported issues pushing the concerto coil out from within its introducer sheath during preparation.Therefore, it is possible that the implant coil became damaged during return of the implant coil back into the introducer sheath.It is possible insufficient preparation of the concerto coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.There was no indication that the event was related to a potential manufacturing issue, so a device history record review is not required.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the coil was stuck in the sheath, so it was replaced without further complication.The patient was undergoing gastroduodenal artery embolization.It was noted that the patient's blood flow and vessel tortuosity were normal.The devices were prepared as indicated per the ifu.There was no damage seen to the coil or catheter.There were no related patient symptoms.Ancillary devices include a maestro 2.8f microcatheter.Additional information received indicated the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13173488
• Report Number: 2029214-2022-00007
• Device Sequence Number: 14607436
• Product Code: KRD
• UDI-Device Identifier: 00847536033788
• UDI-Public: 00847536033788
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2022

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: 02/28/2023
• Device Model Number: PV-6-20-3D
• Device Catalogue Number: PV-6-20-3D
• Device Lot Number: A984778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male