MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	02/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second of 2 reports.
Event or Problem Description
It was reported that during coil embolization of aneurysm there was a thrombus present on the coil detachment zone of the coil.Multiple attempts were made to put the first coil and then second coil (subject coil) in the aneurysm without success.Both the coils were removed and procedure was completed with a third of the same device without patient complications.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed; review and analysis of all available information failed to indicate an assignable cause or probable assignable cause for the reported event.Based on the information available the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that during coil embolization of aneurysm there was a thrombus present on the coil detachment zone of the coil.Multiple attempts were made to put the first coil and then second coil (subject coil) in the aneurysm without success.Both the coils were removed and procedure was completed with a third of the same device without patient complications.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However vessel thrombosis is a known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to reported thrombosis.
Event or Problem Description
It was reported that during coil embolization of aneurysm there was a thrombus present on the coil detachment zone of the coil.Multiple attempts were made to put the first coil and then second coil (subject coil) in the aneurysm without success.Both the coils were removed and procedure was completed with a third of the same device without patient complications.

• Brand Name: TARGET HELICAL ULTRA 2 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6430281
• Report Number: 3008881809-2017-00084
• Device Sequence Number: 735934
• Product Code: HCG
• UDI-Device Identifier: 04546540676016
• UDI-Public: 04546540676016
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K102672
• 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,Followup
• Report Date (Section B): 07/05/2017

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: 06/30/2018
• Device Catalogue Number: M0035432060
• Device Lot Number: 18429984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided; 06/09/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 06/06/2017; 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other