MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during coil embolization procedure, the subject coil was stretched and perforated the aneurysm.No known clinical impact to the patient reported.No additional information was provided.
Event or Problem Description
It was reported that during coil embolization procedure for aneurysm located at the anterior communicating artery (acom), the subject coil perforated the aneurysm.No known clinical consequences to the patient reported.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device remained implanted; therefore, visual, dimensional and functional testing could not be performed.In the case of this complaint, the reported issue is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device direction for use (dfu); therefore, a probable cause of anticipated procedural complication was assigned to the as reported issue patient aneurysm burst/ruptured.Executive summary: updated to include that the subject coil was not stretched and the procedure was for an aneurysm located at the anterior communicating artery (acom).Catalog #: corrected.Lot #: corrected to unknown.Date of implant.Concomitant products grid: added.Initial reporter name: updated.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8209552
• Report Number: 3008881809-2019-00002
• Device Sequence Number: 229122
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: 07613327128284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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 Catalogue Number: M0035421030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other