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

Catalog Number	M0036101850
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1st out of the 2 reports.The subject device is not available.
Event or Problem Description
During placement of the first coil (subject device) into a pulmonary arteriovenous fistula, as the first coil was placed, it jammed and stretched.Unsuccessfully attempts to snare the coil were performed.The stretched portion of the first coil remained in the patient vessel.The physician continued the procedure by placing a second coil followed by unsuccessful detachment attempts.It was reported that when second coil was being removed, it detached prematurely remaining inside the patient.It is unknown if there were attempts to remove the second coil.The event indicates that the physician continued the procedure by deploying 20 coils to occlude the fistula without any problem.No further information is available.
Additional Manufacturer Narrative
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 prior to use.Based on the information currently available the exact cause for the reported issue cannot be determined.This report 1 out of 2.
Event or Problem Description
During placement of the first coil (subject device) into a pulmonary arteriovenous fistula, as the first coil was placed, it jammed and stretched.Unsuccessfully attempts to snare the coil were performed.The stretched portion of the first coil remained in the patient vessel.The physician continued the procedure by placing a second coil followed by unsuccessful detachment attempts.It was reported that when second coil was being removed, it detached prematurely remaining un-retrieved inside the pulmonary artery.The event indicated that to prevent the coil from migration it was secured by deploying 20 coils to occlude the fistula without any problem.Patient current condition was reported as stable.

• Brand Name: TARGET XL 360 STANDARD 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: 6404419
• Report Number: 3008881809-2017-00074
• Device Sequence Number: 1081788
• Product Code: HCG
• UDI-Device Identifier: 07613327004724
• UDI-Public: (01)07613327004724(17)180930(10)18617711
• Combination Product (Y/N): N
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 09/30/2018
• Device Catalogue Number: M0036101850
• Device Lot Number: 18617711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 05/24/2017
• 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: Required Intervention
• Patient Age: 38 YR