MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH SYNCHRO 2/14 300 CM STANDARD; WIRE, GUIDE, CATHETER

Catalog Number M00326510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage, Cerebral (1889); Vascular Dissection (3160)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that a procedure had taken place to implant a flow diverter in a wide-necked aneurysm at the level of the medium cerebral artery.The patient was pre-treated with aspirin, plavix, a vasodilator to prevent arteries spasm and with a double anti-aggregation therapy.Catheterization of the vessel was performed with the microcatheter , distal access catheter and a guidewire (subject device).The patient had a complex anatomy and the three devices were placed in the distal (m3) in order to obtain the necessary support to stretch the micro catheter and to have a normal aspect in the middle cerebral artery.A distal dissection occured when the microcatheter and guidewire (subject device) were being placed in the m3 leading to cerebral hemorrhage in the left m3.The hemorrhage was stopped by implanting three coils and some ml of onyx through the microcatheter.The procedure was terminated without treating the aneurysm and a scan at the end of the procedure showed a hematoma in the middle cerebral artery.New platelets were injected to reverse the effects of the double anti-aggregation therapy given at the beginning of the procedure.A second scan confirmed that the hematoma was increasing and a decompressive craniotomy was performed later in the evening in attempt to diffuse the hematoma.A third scan showed regression of the mass effect, the ventricle was a normal size and intracranial pressure stabilized as well.The patient remains hospitalized in stable condition.No further information is available.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.Cerebral hemorrhage, hematoma and dissection are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu); therefore, anticipated in nature.However, because the device was not returned the exact cause for the difficulties encountered with the device cannot be definitively determined.

Event Description

It was reported that a procedure had taken place to implant a flow diverter in a wide-necked aneurysm at the level of the medium cerebral artery.The patient was pre-treated with aspirin, plavix, a vasodilator to prevent arteries spasm and with a double anti-aggregation therapy.Catheterization of the vessel was performed with the microcatheter , distal access catheter and a guidewire (subject device).The patient had a complex anatomy and the three devices were placed in the distal (m3) in order to obtain the necessary support to stretch the micro catheter and to have a normal aspect in the middle cerebral artery.A distal dissection occured when the microcatheter and guidewire (subject device) were being placed in the m3 leading to cerebral hemorrhage in the left m3.The hemorrhage was stopped by implanting three coils and some ml of onyx through the microcatheter.The procedure was terminated without treating the aneurysm and a scan at the end of the procedure showed a hematoma in the middle cerebral artery.New platelets were injected to reverse the effects of the double anti-aggregation therapy given at the beginning of the procedure.A second scan confirmed that the hematoma was increasing and a decompressive craniotomy was performed later in the evening in attempt to diffuse the hematoma.A third scan showed regression of the mass effect, the ventricle was a normal size and intracranial pressure stabilized as well.The patient remains hospitalized in stable condition.No further information is available.

• Brand Name: SYNCHRO 2/14 300 CM STANDARD
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH; 2405 orion circle; west valley city UT 84119
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH; 2405 orion circle; west valley city UT 84119
• Manufacturer Contact: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6289971
• MDR Text Key: 66164264
• Report Number: 3008880413-2017-00004
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)190731(10)B42505
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K053268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: M00326510
• Device Lot Number: B42505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• 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: AXS DISTAL ACCESS CATHETER (STRYKER); XT-17 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR