MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121450
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	08/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second of 2 reports.Reference to medwatch report mw5065280 filed by the facility.Subject device is not available.
Event or Problem Description
The patient presented with a ruptured large supraclinoid right internal carotid artery (ica) aneurysm with subarachnoid hemorrhage and mild hydrocephalus.During embolization of the aneurysm, the fist coil was placed inside the aneurysm but stretched out of the aneurysm and down the vasculature and broke off the delivery wire.Following unsuccessful attempts to retrieve the coil, a stent was placed to secure the broken stretched coil against the right ica wall.The same issue was occurred with the second coil (subject coil).The third coil was uneventfully placed; however, after the last coil deployment, thrombus formation was noted at the treated vessel.Intra-arterial integrilin was given to the patient to treat the vessel thrombosis.The patient had long term deficit with speech, cognitive and linguistic deficits requiring 24 hour supervision for safety.It is unknown if the patients condition post-procedure related to the reported devices malfunction and subsequent thrombosis or to the patients presenting condition before procedure.
Additional Manufacturer Narrative
This report is to inform the food and drug administration about a duplicate.A medwatch report (mw 5065280) was received on 18-october-2016 regarding adverse events for subject coils.At the time mfr report # 3008881809-2016-00260 for the 1st coil (along with the mfr report # 3008881809-2016-00259 for the 2nd coil and mfr report # 3008881809-2016-00287 for the last coil) was filed with an awareness date of 18-october-2016.A search for information already entered in our system was done without finding any duplicate.On 11 january-2017, investigation team identified that this report is a duplicate of mfr report # 3008881809-2016-00169 (for the 1st coil) for the same event on date 22-august-2016.Mfr report # 3008881809-2016-00169 had been created earlier based on sales representative information with an awareness date of 08/22/2016.In both records, the facility name and address were different but zip code and all other information were similar hence the duplicate records could not be identified earlier.Henceforth any follow up on this event or additional information will be filed under mfr report # 3008881809-2016-00169 and no further follow-up will be filed under the mfr report # 3008881809-2016-00260 will be filed.
Event or Problem Description
The patient presented with a ruptured large supraclinoid right internal carotid artery (ica) aneurysm with subarachnoid hemorrhage and mild hydrocephalus.During embolization of the aneurysm, the fist coil was placed inside the aneurysm but stretched out of the aneurysm and down the vasculature and broke off the delivery wire.Following unsuccessful attempts to retrieve the coil, a stent was placed to secure the broken stretched coil against the right ica wall.The same issue was occurred with the second coil (subject coil).The third coil was uneventfully placed; however, after the last coil deployment thrombus formation was noted at the treated vessel.Intra-arterial integrilin was given to the patient to treat the vessel thrombosis.The patient had long term deficit with speech, cognitive and linguistic deficits requiring 24 hour supervision for safety.It is unknown if the patient¿s condition post-procedure related to the reported devices malfunction and subsequent thrombosis or to the patient¿s presenting condition before procedure.

• Brand Name: TARGET XL 360 SOFT 14MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6105930
• Report Number: 3008881809-2016-00260
• Device Sequence Number: 10930804
• Product Code: HCG
• UDI-Device Identifier: 04546540711540
• UDI-Public: (01)04546540711540(17)190228(10)18839198
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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 Catalogue Number: M0036121450
• Device Lot Number: 18839198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 02/06/2017
• 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: 2 TARGET COIL (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR