MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT 27 MICROCATHETER ST 135; CATHETER, PERCUTANEOUS

Catalog Number M003XT2735810

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

Patient Problems Aneurysm (1708); Death (1802); Hemorrhage, Subarachnoid (1893); Rupture (2208)

Event Date 01/31/2017

Event Type  Death  

Manufacturer Narrative

The subject deivce is not available.

Event Description

During a stent assisted coiling embolization of an unruptured terminus aneurysm, it was reported that the patient experienced a significant hemorrhage.The hemorrhage was due to the aneurysm rupture caused by the pressure of the microcatheter (subject device) and the guidewire to the back wall of the aneurysm.The patient was reported to be have died and the exact date of the death is unknown.No further information is available.

Manufacturer Narrative

Although the device history record could not be reviewed because the batch remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The device was not available for analysis.However, aneurysm rupture, hemorrhage and death are known and anticipated complications to these types of procedures and are noted in the labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.

Event Description

During a stent assisted coiling embolization of an unruptured terminus aneurysm, it was reported that the patient experienced a significant hemorrhage.The hemorrhage was due to the aneurysm rupture caused by the pressure of the microcatheter (subject device) and the guidewire to the back wall of the aneurysm.The patient was reported to be have died and the exact date of the death is unknown.No further information is available.

• Brand Name: EXCELSIOR XT 27 MICROCATHETER ST 135
• 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: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6368312
• MDR Text Key: 68658315
• Report Number: 3008881809-2017-00058
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113778
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003XT2735810
• Device Lot Number: 18994290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• 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
• Patient Outcome(s): Death; Other