MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number M0031681900

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Paresis (1998); No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

The patient presented with an anuerysm in the right middle cerebral artery (mca) and a pre-procedure national institute of health stroke scale (nihss) and modified rankin scale (mrs) score of 0.It was reported that 1 day after a stent assisted coiling procedure, the patient experienced paresis of the left arm.Computed tomography (ct) and ct perfusion imaging did not show any sign of infarction or hemorrhage; the patient's symptoms resolved without sequelae within 2 days and mrs score post event was (b)(6), complete obliteration.According to the physician, the guidewire, microcatheter and stent used in procedure and the patient's low blood pressure at the end of general anesthesia and during extubation could have contributed to the paresis.

Manufacturer Narrative

The device history record (dhr) could not be reviewed because the lot number was not reported.The subject device was not returned for analysis, therefore physical and functional evaluations could not be performed.However, the reported left arm paresis (neurological/intracranial sequelae) is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu).Based on the information available, an assignable cause of known inherent risk of procedure was assigned to this event.

Event Description

The patient presented with an anuerysm in the right middle cerebral artery (mca) and a pre-procedure national institute of health stroke scale (nihss) and modified rankin scale (mrs) score of 0.It was reported that 1 day after a stent assisted coiling procedure, the patient experienced paresis of the left arm.Computed tomography (ct) and ct perfusion imaging did not show any sign of infarction or hemorrhage; the patient's symptoms resolved without sequelae within 2 days and mrs score post event was class 1, complete obliteration.According to the physician, the guidewire, microcatheter and stent used in procedure and the patient's low blood pressure at the end of general anesthesia and during extubation could have contributed to the paresis.

Event Description

The patient presented with an anuerysm in the right middle cerebral artery (mca) and a pre-procedure national institute of health stroke scale (nihss) and modified rankin scale (mrs) score of 0.It was reported that 1 day after a stent assisted coiling procedure, the patient experienced paresis of the left arm.Computed tomography (ct) and ct perfusion imaging did not show any sign of infarction or hemorrhage; the patient's symptoms resolved without sequelae within 2 days and mrs score post event was class 1, complete obliteration.According to the physician, the guidewire, microcatheter and stent used in procedure and the patient's low blood pressure at the end of general anesthesia and during extubation could have contributed to the paresis.

Manufacturer Narrative

Information reviewed on 20 december-2019 mentioned that according to the study electronic data capture (edc), the adverse event of patient left arm paresis was not related to study stent or any other stryker ancillary products, microcatheter (subject device), or guidewire.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7380285
• MDR Text Key: 103771973
• Report Number: 3008881809-2018-00137
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0031681900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUROFORM ATLAST STENT SYSTEM (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 43 YR