MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452040
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device remains implanted.
Event or Problem Description
A (b)(6) female (hypertension, previous smoker) underwent stent assisted coil embolization of aneurysm in right middle cerebral artery (mca) (b)(6) 2017.When the patient was seen for follow-up approximately one year later (b)(6) 2018, it was reported the coil migrated through the stent struts and was protruding slightly into the artery, as observed on dsa (digital subtraction angiography) imaging.There was no clinical consequence to the patient as a result; the event was noted to resolve without sequelae the same day ((b)(6) 2018).Additional information from the physician indicated the stent was used successfully.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The cause of the reported issue could not be definitively determined.
Event or Problem Description
A (b)(6) female (hypertension, previous smoker) underwent stent assisted coil embolization of aneurysm in right middle cerebral artery (mca) (b)(6) 2017.When the patient was seen for follow-up approximately one year later (b)(6) 2018, it was reported the coil migrated through the stent struts and was protruding slightly into the artery, as observed on dsa (digital subtraction angiography) imaging.There was no clinical consequence to the patient as a result; the event was noted to resolve without sequelae the same day (b)(6) 2018).Additional information from the physician indicated the stent was used successfully.

• Brand Name: TARGET HELICAL NANO 2 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7928892
• Report Number: 3008881809-2018-00425
• Device Sequence Number: 1936209
• Product Code: HCG
• UDI-Device Identifier: 07613252600374
• UDI-Public: 07613252600374
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: M0035452040
• Device Lot Number: 19757643
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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: HEADWAY 17 CATHETER (MICROVENTION); HEADWAY DUO MICROCATHETER (MICROVENTION); NEUROFORM ATLAS STENT (STRYKER); TARGET COIL (STRYKER); TARGET COIL (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 59 YR