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

Catalog Number M0031681900

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

Patient Problems Aneurysm (1708); Infarction, Cerebral (1771); Death (1802); Hemorrhage, Subarachnoid (1893); Rupture (2208)

Event Date 04/03/2015

Event Type  Death  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

The patient presented with an unruptured basilar tip aneurysm for stent assisted coiling.While the guidewire inside the microcatheter (subject device) was being advanced to the target aneurysm lesion, the aneurysm ruptured resulting in bleeding.Both devices were not in the aneurysm at the time of rupture.There was no device malfunction noted to both devices.Heparin was reversed with protamine and stent assisted embolization was performed and completed.During this time it was noted that blood flow to the posterior fossa was not detected due to increased intracranial pressure.Emergent ventriculostomy was performed.Post procedure imaging showed an extensive subarachnoid hemorrhage (sah) with cerebral infarctions and brain damage.The patient was discharged to the hospice care and subsequently died 10 days post procedure.The cause of death was sequel (extensive cerebral infarctions) of acute increased intracranial pressure that resulted from the intraprocedural aneurysm rupture.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The device was not available for analysis.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.Aneurysm rupture, hemorrhage, stroke 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

The patient presented with an unruptured basilar tip aneurysm for stent assisted coiling.While the guidewire inside the microcatheter (subject device) was being advanced to the target aneurysm lesion, the aneurysm ruptured resulting in bleeding.Both devices were not in the aneurysm at the time of rupture.There was no device malfunction noted to both devices.Heparin was reversed with protamine and stent assisted embolization was performed and completed.During this time it was noted that blood flow to the posterior fossa was not detected due to increased intracranial pressure.Emergent ventriculostomy was performed.Post procedure imaging showed an extensive subarachnoid hemorrhage (sah) with cerebral infarctions and brain damage.The patient was discharged to the hospice care and subsequently died 10 days post procedure.The cause of death was sequel (extensive cerebral infarctions) of acute increased intracranial pressure that resulted from the intraprocedural aneurysm rupture.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK (MDR); ida industrial estate; model farm road; cork
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK (MDR); ida industrial estate; model farm road; cork
• Manufacturer Contact: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5025051
• MDR Text Key: 23850657
• Report Number: 3008853977-2015-00342
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2016
• Device Catalogue Number: M0031681900
• Device Lot Number: 18038597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• 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
• Patient Age: 69 YR