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

Catalog Number	M0035466300
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the coil placement into a giant internal carotid aneurysm, while the biggest part of the coil was already inside the aneurysm, the coil prematurely detached without using of detachment device.The big part of the coil stayed inside the aneurysm but the small part of the coil protruded into the parent vessel.The whole coil was successfully removed using a snare retrieval device.Another of the same coil was uneventfully implanted into the aneurysm.There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic investigation of the returned device found that the delivery wire was kinked most likely caused by the handling of the device.The main coil was kinked, stretched and physically broken from the delivery wire.No functional test could be performed on the returned device.No other anomalies were noted.Based on the device analysis it is probable that the device was damaged during the clinical procedure causing the coil to become prematurely detached and to protrude from the aneurysm.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.It is likely that some procedural factors encountered during the procedure limited the performance of the device contributing to the reported event and observed damages.Therefore, an assignable cause of procedural factors has been assigned to the event.
Event or Problem Description
It was reported that during the coil placement into a giant internal carotid aneurysm, while the biggest part of the coil was already inside the aneurysm, the coil prematurely detached without using of detachment device.The big part of the coil stayed inside the aneurysm but the small part of the coil protruded into the parent vessel.The whole coil was successfully removed using a snare retrieval device.Another of the same coil was uneventfully implanted into the aneurysm.There were no clinical consequences to the patient due to the reported event.

• Brand Name: TARGET 360 STANDARD 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: 5760433
• Report Number: 3008881809-2016-00060
• Device Sequence Number: 24732
• Product Code: HCG
• UDI-Device Identifier: 07613252239444
• UDI-Public: (01)07613252239444(17)181130(10)18720139
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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): 06/09/2016

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: 11/30/2018
• Device Catalogue Number: M0035466300
• Device Lot Number: 18720139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2016
• Supplement Report FDA Received Date: 11/17/2016
• 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
• Patient Age: 57 YR