MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036124120
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device is not available to the manufacturer.
Event or Problem Description
It was reported during coil embolization procedure, the main coil was delivered into the ophthalmic aneurysm, however the detached coil was protruding out of the aneurysm into the parent vessel.The physician elected to use a flow diverter to prevent aneurysmal filling and push the coil tail to vessel walls.The procedure was completed successfully and there was no clinical consequence to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation 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.Based on the information currently available the exact cause could not be determined, however, it is probable performance was limited due to procedural factors as per the additional information the patient's anatomy was tortuous.Therefore a cause of procedural factors will be assigned to this investigation.
Event or Problem Description
It was reported during coil embolization procedure, the main coil was delivered into the ophthalmic aneurysm, however the detached coil was protruding out of the aneurysm into the parent vessel.The physician elected to use a flow diverter to prevent aneurysmal filling and push the coil tail to vessel walls.The procedure was completed successfully and there was no clinical consequence to the patient.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8799883
• Report Number: 3008881809-2019-00207
• Device Sequence Number: 18887429
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: 07613327128338
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/14/2019

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: 10/08/2021
• Device Catalogue Number: M0036124120
• Device Lot Number: 20930327
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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: PHENOM 027 MICROCATHETER (MEDTRONIC); SL-10 MICROCATHETER (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER); PHENOM 027 MICROCATHETER (MEDTRONIC); SL-10 MICROCATHETER (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR