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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP; CATHETER, PERCUTANEOUS
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STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M0031681890
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Rupture (2208)
Event Date 11/06/2019
Event Type  Injury  
Event Description
It was reported that during coiling procedure of an unruptured anterior communicating artery (a-com) aneurysm, when the 4th coil was deployed with the microcatheter (subject device), the microcatheter perforated the aneurysm wall.According to the physician, the perforation of aneurysm was considered a handling factor.Therefore, the 4th coil was deployed from outside the aneurysm and it was necessary to implant a new coil.The procedure was completed.There was no clinical impact to the patient.
 
Event Description
It was reported that during coiling procedure of an unruptured anterior communicating artery (a-com) aneurysm, when the 4th coil was deployed with the microcatheter (subject device), the microcatheter perforated the aneurysm wall.According to the physician, the perforation of aneurysm was considered a handling factor.Therefore, the 4th coil was deployed from outside the aneurysm and it was necessary to implant a new coil.The procedure was completed.There was no clinical impact to the patient.
 
Manufacturer Narrative
D4: expiration date: updated.H3: device evaluated by mfg: updated.H3: summary attached: updated.H4: manufacturing date: updated.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event could not be confirmed; however, the reported aneurysm rupture is a known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
 
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Brand Name
EXCELSIOR SL-10 150CM 2 TIP
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9468661
MDR Text Key170751998
Report Number3008881809-2019-00389
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K013789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/15/2021
Device Catalogue NumberM0031681890
Device Lot Number21382980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Date Manufacturer Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
4 TARGET COILS (STRYKER); 4 TARGET COILS (STRYKER)
Patient Outcome(s) Other;
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