MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035475200
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization of an unruptured aneurysm, the physician felt resistance while repositioning the subject coil.The subject coil became entangled with the previous coil already in place in the aneurysm, prematurely detached or broke and stretched inside the patient.Different unsuccessful attempts were made to either push back the coil into the aneurysm or capture the distal part of the coil.The broken subject coil was protruding from the aneurysm into the internal carotid artery.The subject coil was retrieved by a snare device dragging the previously implanted coil out of the aneurysm.Both coils were removed successfully and the procedure was completed without patient impact.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject main coil was returned detached from the delivery wire, within an sl-10 microcatheter with another target coil.Visual examination of the returned device revealed that the coil proximal contact and the deliver wire were kinked, the main coil was stretched, prematurely detached and broken, and the coil suture was damaged.During functional testing, the main coil was noted to be jammed inside the returned sl-10 microcatheter.It is likely that the main coil was damaged during advancement causing the reported friction.After experiencing the friction, the coil was attempted to be repositioned several times with resistance noted.Following this manipulation the main coil stretched and detached/broke leading to the reported main coil protrusion and the subsequent unexpected interaction with another device.Therefore, an assignable cause of operational context has been assigned to this investigation.This is the first of 2 reports.
Event or Problem Description
It was reported that during coil embolization of an unruptured aneurysm, the physician felt resistance while repositioning the subject coil.The subject coil became entangled with the previous coil already in place in the aneurysm, prematurely detached or broke and stretched inside the patient.Different unsuccessful attempts were made to either push back the coil into the aneurysm or capture the distal part of the coil.The broken subject coil was protruding from the aneurysm into the internal carotid artery.The subject coil was retrieved by a snare device dragging the previously implanted coil out of the aneurysm.Both coils were removed successfully and the procedure was completed without patient impact.

• Brand Name: TARGET 360 SOFT 5MM 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: 5673830
• Report Number: 3008881809-2016-00006
• Device Sequence Number: 18834333
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: (01)04546540676511(17)190213(10)18854618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112385
• 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): 04/26/2016

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: 02/28/2019
• Device Catalogue Number: M0035475200
• Device Lot Number: 18854618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 11/02/2016
• 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: Required Intervention