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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM CATHETER, PERCUTANEOUS

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STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M003XT2750810
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Paresis (1998); Perforation of Vessels (2135); Brain Injury (2219); Loss of consciousness (2418)
Event Date 12/20/2021
Event Type  Injury  
Manufacturer Narrative
2 of 4 mdrs. The device is not available to the manufacturer.
 
Event Description
It was reported that during the treatment of a micro- perforation to the m2 of the left mca, physician used the subject microcatheter and guidewires to deploy stent. He re-sheathed the stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch. 15 minutes post deployment physician noticed contrast leaking distal to the stent indicating vessel perforation. On review of imaging, it was cleared that the perforation happened before stent deployment and after the placement of subject microcatheter and guidewires. It is undeterminable if the devices caused the perforation. Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin. 4 hours post procedure patient started bleeding again at m1/m2 bifurcation. Another surgery was performed to remove the blood from brain and the stent was seen protruding from the vessel. It is undeterminable if the stent caused the perforation. Patient suffered paralysis and is currently in icu. No additional information available.
 
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Brand NameEXCELSIOR XT-27 STD STRAIGHT 150CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key13310764
MDR Text Key286656329
Report Number3008881809-2022-00028
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113778
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 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberM003XT2750810
Device Lot Number23140475
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2021
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: 01/20/2022 Patient Sequence Number: 1
Treatment
AXS INFINITY LONG SHEATH (STRYKER); AXS VECTA INTERMEDIATE CATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); SELECT CATHETER (PENUMBRA); SURPASS EVOLVE FLOW DIVERTING STENT (STRYKER); SYNCHRO 10 GUIDEWIRE (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)
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