MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK MATRIX2 ULTRASOFT SR 3MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M003497320SR0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during coil embolization of an aneurysm, when half of the coil (subject device) was already inside the aneurysm sac, the coil elongated/stretched and the physician was not able to control the coil.The coil broke into 2 parts.The part of the coil inside the aneurysm was successfully removed using a remover device.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during coil embolization of an aneurysm, when half of the coil (subject device) was already inside the aneurysm sac, the coil elongated/stretched and the physician was not able to control the coil.The coil broke into 2 parts.The part of the coil inside the aneurysm was successfully removed using a remover device.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The device was returned along with a second matrix coil and a non- stryker microcatheter with a snare device inserted.Visual examination of the returned device revealed that the distal end of the coil was broken and stretched, the proximal end of the coil was attached to the delivery wire and it was contained within the introducer sheath, the coil was unable to be removed from the introducer sheath.During functional test, the snare device was removed from the returned microcatheter.A 0.0184¿ patency mandrel was advanced through the inner lumen of the returned microcatheter without difficulty.A 0.020¿ mandrel would not pass.The introducer sheath was flushed and the coil was unable to be removed from the introducer sheath.Based on the information available and analysis of the device, it is probable that the coil stretched and then broke while the coil was being pushed and pulled within the microcatheter against friction.This was most likely due to some procedural/anatomical factors encountered during use.The damaged coil got stuck inside the introducer sheath and could not be removed during device analysis.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of procedural factors has been assigned to this investigation.

• Brand Name: MATRIX2 ULTRASOFT SR 3MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7660683
• Report Number: 3008881809-2018-00297
• Device Sequence Number: 10807010
• Product Code: HCG
• UDI-Device Identifier: 04546540691699
• UDI-Public: 04546540691699
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K050700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: M003497320SR0
• Device Lot Number: 19573015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR