MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036121040

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Stroke/CVA (1770); Hemorrhage, Subarachnoid (1893); Dysphasia (2195); Ptosis (2620)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

The device remains implanted.

Event Description

It was reported that the microcatheter was pushed out of the left ophthalmic internal carotid artery (ica) aneurysm during the delivery of the subject coil resulting in the distal end of the coil becoming stuck between the "intra-aneurysmal coil-ball".The physician was unable to retrieve the coil and the coil was stretched.The physician pulled back the microcatheter with the coil inside, and placed a stent over the stretched portion of the coil at the level of the ica bifurcation, and detached the coil.After extubating the patient post procedure, the patient had aphasia and left ptosis.The magnetic resonance angiogram (mra) showed a left subarachnoid hemorrhage.There was no treatment administered but it was reported that 11 days post procedure adverse events were resolved without sequelae.The physician stated that the adverse events were not related to the "stretching coil" but it was related to the maneuver necessary to deliver other devices.Pre and post procedure the patient's modified rankin scale was measured of 1.

Manufacturer Narrative

The device history record review confirms 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.Information available, indicated that the main coil appeared to have gotten entangled with previously placed coils in the aneurysm.The patient complications (hemorrhage, stroke and subsequent neurological deficits) although anticipated in nature, are likely to have occurred, in part as a result of the damage sustained to the subject coil.An assignable cause of operational context has been assigned to this complaint as procedural factors encountered limited the performance of the device contributing to the reported event.

Event Description

It was reported that the microcatheter was pushed out of the left ophthalmic internal carotid artery (ica) aneurysm during the delivery of the subject coil resulting in the distal end of the coil becoming stuck between the ¿intra-aneurysmal coil-ball¿.The physician was unable to retrieve the coil and the coil was stretched.The physician pulled back the microcatheter with the coil inside, and placed a stent over the stretched portion of the coil at the level of the ica bifurcation, and detached the coil.After extubating the patient post procedure, the patient had aphasia and left ptosis.The magnetic resonance angiogram (mra) showed a left subarachnoid hemorrhage.There was no treatment administered but it was reported that 11 days post procedure adverse events were resolved without sequelae.The physician stated that the adverse events were not related to the ¿stretching coil¿ but it was related to the maneuver necessary to deliver other devices.Pre and post procedure the patient¿s modified rankin scale was measured of 1.

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5998827
• MDR Text Key: 56441063
• Report Number: 3008881809-2016-00199
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: (01)07613327004601(17)190731(10)19185282
• Combination Product (y/n): N
• PMA/PMN Number: K123377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: M0036121040
• Device Lot Number: 19185282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: .27¿¿ MICROCATHER (UNKNOWN MANUFACTURER); 15 TARGET COILS (STRYKER); DERIVO® FLOW DIVERTER (ACANDIS (B)(4) & CO); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR