MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 1st of 2 mdrs.
Event or Problem Description
It was reported that during coil embolization procedure, resistance was encountered when advancing the coil though the microcatheter and the subject coil and micorcatheter perforated the aneurysm.The physician was able to remove both coil and micorcatheter from the patient¿s anatomy and the procedure was completed.No known patient consequences were reported due to this event.No additional information was provided.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the delivery wire was noted to be kinked.During functional testing, the coil in catheter test was performed using the sl-10 microcatheter that was returned for this complaint.Friction was encountered when advancing the coil through the catheter.In case of this complaint, it is most likely that friction between the target coil and the sl-10 microcatheter was met due to the catheter being kinked/bent.The catheter was kinked most likely due to some procedural factors encountered during use.In this case, it was also reported that the target coil and the sl-10 microcatheter perforated the aneurysm.It is likely that the catheter together with the coil erratically moved while the physician was pushing the coil against friction, causing the reported aneurysm rupture; however, this cannot be conclusively determined.The reported aneurysm rupture is a known anticipated complication to this type of procedures and patient condition and is listed as such in the device direction for use; therefore, a probable cause of anticipated procedural complication was assigned to the as reported issue aneurysm rupture.
Event or Problem Description
It was reported that during coil embolization procedure, resistance was encountered when advancing the coil though the microcatheter and the subject coil and micorcatheter perforated the aneurysm.The physician was able to remove both coil and micorcatheter from the patient¿s anatomy and the procedure was completed.No known patient consequences were reported due to this event.No additional information was provided.

• Brand Name: TARGET 360 NANO 2.5 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8536096
• Report Number: 3008881809-2019-00107
• Device Sequence Number: 16243324
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: 07613252600305
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• 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): 06/13/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2021
• Device Catalogue Number: M0035442540
• Device Lot Number: 20610686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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: EXCELSIOR SL-10 MICORCATHETER (STRYKER); EXCELSIOR SL-10 MICORCATHETER (STRYKER)