MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 5MMX20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035465200
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during coil embolization procedure for aneurysm located at the right posterior communicating artery, the physician tried to use the subject coil to complete the procedure.The subject coil could not be advanced into the lumen of the aneurysm.The physician tried to adjust the coil; however, the coil was noted to be stretched.When the physician tried to remove the coil by deploying a stent, the coil broke in the middle and some part of the coil was left inside the patient¿s vessel.No additional medical intervention was performed at this time.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the delivery wire was found kinked and the main coil was broken from the etch link confirming the reported complaint.Functional testing could not be performed due the condition of the returned device.During device inspection, it was confirmed that the main coil was broken at the etch link.It is probable that the coil was damaged during advancement/ repositioning causing the reported events.An assignable cause of procedural factors was assigned to the as reported 'main coil stretched', unretrieved device fragments', ¿coil in catheter friction¿, 'main coil migration' and 'coil broken/fractured' and to the as analyzed ¿main coil broken/fractured¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.An assignable cause of handling damage was assigned to the as analyzed 'coil delivery wire kinked/bent' as the issue is due to handling of the device or portion of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.
Event or Problem Description
It was reported that during coil embolization procedure for aneurysm located at the right posterior communicating artery, the physician tried to use the subject coil to complete the procedure.The subject coil could not be advanced into the lumen of the aneurysm.The physician tried to adjust the coil; however, the coil was noted to be stretched.When the physician tried to remove the coil by deploying a stent, the coil broke in the middle and some part of the coil was left inside the patient¿s vessel.No additional medical intervention was performed at this time.

• Brand Name: TARGET 360 STANDARD 5MMX20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7657640
• Report Number: 3008881809-2018-00295
• Device Sequence Number: 2629888
• Product Code: HCG
• UDI-Device Identifier: 07613252239420
• UDI-Public: 07613252239420
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K153658
• 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): 08/31/2018

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: 02/28/2021
• Device Catalogue Number: M0035465200
• Device Lot Number: 20302578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 08/12/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/31/2018
• 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 XT-27 MICROCATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 62