MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED J 150CM; CATHETER, PERCUTANEOUS

Catalog Number M0031681920

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

Patient Problems Aneurysm (1708); Hemorrhage, Subarachnoid (1893); Rupture (2208)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

During the stent assisted coil embolization procedure for the a-com unruptured aneurysm (dome 16 mm/ neck 7 mm), a (non stryker) microcatheter was advanced into the aneurysm and the other microcatheter (subject device) was advanced to a2.It was reported that when a stent was advanced in the subject microcatheter over the aneurysm neck, an increase in blood pressure was noticed and the contrast leaking from the aneurysm was confirmed through angiography.However; the physician could not identify the source of bleeding, he thought that the bleeding source was coming from the neck of the aneurysm.Then the stent was deployed a2 to a1 and the coil was implanted.External ventricular drainage was done and hemorrhage was confirmed hours later.The patient condition was severe.No further information is available now.

Manufacturer Narrative

A review of the device history record could not be performed because the lot number was not reported.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, the reported aneurysm rupture and hemorrhage are known risks associated with endovascular procedures and are listed as such in the device directions for use.Therefore, an assignable cause of known inherent risk of procedure has been assigned to the reported aneurysm rupture and hemorrhage.

Event Description

During the stent assisted coil embolization procedure for the a-com unruptured aneurysm (dome 16mm/ neck 7mm), a (non stryker) microcatheter was advanced into the aneurysm and the other microcatheter (subject device) was advanced to a2.It was reported that when a stent was advanced in the subject microcatheter over the aneurysm neck, an increase in blood pressure was noticed and the contrast leaking from the aneurysm was confirmed through angiography.However; the physician could not identify the source of bleeding, he thought that the bleeding source was coming from the neck of the aneurysm.Then the stent was deployed a2 to a1 and the coil was implanted.External ventricular drainage was done and hemorrhage was confirmed hours later.The patient condition was severe.No further information is available now.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED J 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 6996648
• MDR Text Key: 90882415
• Report Number: 3008881809-2017-00462
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K042568
• 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: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0031681920
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ECHELON 10 MICROCATHETER (MEDTRONIC); NEUROFORM ATLAS STENT (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR