MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442030
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization procedure, the finishing fourth coil (subject device) did not detached inside the aneurysm.The physician pulled the delivery wire and the coil altogether and the coil detached.The subject coil was protruding from the aneurysm into the parent vessel and was fixed by stenting.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that no damage was noted to the packaging of the device and continuous flush was maintained.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the reported issues.
Event or Problem Description
It was reported that during coil embolization procedure, the finishing fourth coil (subject device) did not detached inside the aneurysm.The physician pulled the delivery wire and the coil altogether and the coil detached.The subject coil was protruding from the aneurysm into the parent vessel and was fixed by stenting.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
G4: reportability awareness date in initial mfr report #3008881809-2019-00246: corrected from initially recorded as 11-jul-2019 to 15-aug-2019.A cross-functional meeting was convened with stryker japan cic (complaint intake center) team, sales team and fremont, california cmc (complaint management center) team on 12- sep-2019, thursday to talk about the events regarding this mdr report.We discussed and agreed that the stryker japan sales team attended the live bsnet case on 11-jul-2019, the stryker team was not made aware of any product malfunction during or post procedure.Additional information was updated when the physicians ¿ dr.Sakai and dr.Imamura further discussed the case details with stryker japan sales and marketing team on 15-aug-2019 and so the awareness date of the reportable allegation against the stryker device (subject device coil) was confirmed to be 15-aug-2019.
Event or Problem Description
It was reported that during coil embolization procedure, the finishing fourth coil (subject device) did not detached inside the aneurysm.The physician pulled the delivery wire and the coil altogether and the coil detached.The subject coil was protruding from the aneurysm into the parent vessel and was fixed by stenting.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 2 MM X 3 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8908458
• Report Number: 3008881809-2019-00246
• Device Sequence Number: 2731239
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: 07613252600312
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019

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: 03/09/2022
• Device Catalogue Number: M0035442030
• Device Lot Number: 21268685
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 09/12/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/11/2019; 09/30/2019
• 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 SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention