MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035476300
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the embolization procedure, it was reported that the coil broke while withdrawing the microcatheter from the aneurysm.The part of the main coil was still attached to the delivery wire and 2 loops of the main coil were protruding from the aneurysm into the parent vessel.The broken coil which was attached to the delivery wire was safely removed from the patient.A stent was placed across the lesion to secure protruded loops of the coil inside the aneurism.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
Product available to stryker/device evaluated by mfg: updated.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device visual inspection discovered that the main coil returned without an introducer sheath or delivery wire.The functional and dimensional testing could not be performed due to condition of the returned device.Microscopic evaluation revealed that the main coil was heavily stretched and broken in multiple locations and had damaged suture.In addition, the coil had traces of procedural fluid which likely contributed to detachment issues during the procedure.Information available indicated that the device was in good condition prior to use and the user spend about 45 minutes reposioning the coil.It is possible that the product was damaged during advancement/re-positioning contributing to the reported event.Therefore, based on device analysis and all available information an assignable cause of operational context was assigned to the reported event.
Event or Problem Description
During the embolization procedure, it was reported that the coil broke while withdrawing the microcatheter from the aneurysm.The part of the main coil was still attached to the delivery wire and 2 loops of the main coil were protruding from the aneurysm into the parent vessel.The broken coil which was attached to the delivery wire was safely removed from the patient.A stent was placed across the lesion to secure protruded loops of the coil inside the aneurism.There were no clinical consequences to the patient due to this event.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6316235
• Report Number: 3008881809-2017-00038
• Device Sequence Number: 532996
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: (01)04546540676559(17)190531(10)19083693
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 06/13/2017

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: 05/31/2019
• Device Catalogue Number: M0035476300
• Device Lot Number: 19083693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 06/13/2017
• 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: 52 YR