MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 18MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181850
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the embolization procedure against type ii endoleak after endovascular aortic repair, it was reported that the coil got stuck and stretched inside the microcatheter during placement in an inferior mesenteric artery aneurysm.The physician attempted to remove the coil together with the microcatheter but it did not work.Therefore, a snare device was used but still did not work.Finally the physician cut off the coil, part of the main coil was left inside the patient located from abdominal aortic aneurysm to inferior mesenteric artery.The procedure was aborted due to 3 hours had passed since coil retrieving started and the inferior mesenteric artery became spasm.The patient condition is fine but is under observation at the moment.
Additional Manufacturer Narrative
Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available indicated that the device was confirmed to be in good condition after unpacking and the device was prepared as per the dfu.And intermittent flush was maintained.Based on the information currently available, it is possible that the main coil encountered friction inside microcatheter, got stuck and stretched due to lack of continuous flush maintained during the procedure.Then the coil was cut off, and the coil migrated inside patient body and became un-retrievable resulting in vasospasm.As per dfu maintaining continuous flush throughout the procedure is a critical requirement as lack of it can result in increased friction.Therefore, an assignable cause of ¿user error¿ will be assigned to reported event, as the investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
During the embolization procedure against type¿endoleak after endovascular aortic repair, it was reported that the coil got stuck and stretched inside the microcatheter during placement in an inferior mesenteric artery aneurysm.The physician attempted to remove the coil together with the microcatheter but it did not work.Therefore, a snare device was used but still did not work.Finally the physician cut off the coil, part of the main coil was left inside the patient located from abdominal aortic aneurysm to inferior mesenteric artery.The procedure was aborted due to 3 hours had passed since coil retrieving started and the inferior mesenteric artery became spasm.The patient condition is fine but is under observation at the moment.

• Brand Name: TARGET XXL 360 18MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6901429
• Report Number: 3008881809-2017-00386
• Device Sequence Number: 11019557
• Product Code: HCG
• UDI-Device Identifier: 07613327128413
• UDI-Public: (01)07613327128413(17)191031(10)19381875
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 11/28/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: M0036181850
• Device Catalogue Number: M0036181850
• Device Lot Number: 19381875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/28/2017
• 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: CARNELIAN MICROCATHETER ((B)(4) MEDICAL PRODUCTS)
• Outcome Attributed to Adverse Event: Other; Required Intervention