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U.S. Department of Health and Human Services

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

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STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM CATHETER, PERCUTANEOUS Back to Search Results
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.

 
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Brand NameEXCELSIOR SL-10 PRE-SHAPED 45 150CM
Type of DeviceCATHETER, 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 Key7380285
MDR Text Key103771973
Report Number3008881809-2018-00137
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK042568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
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 Received03/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberM0031681900
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
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 TREATMENT DATA
Date Received: 03/28/2018 Patient Sequence Number: 1
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