MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP; CATHETER, PERCUTANEOUS

Catalog Number M0031681890

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

Patient Problem Headache (1880)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

This is tenth of 10 reports filed associated with this event.

Event Description

The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the internal carotid artery-posterior communicating artery.On the day of the procedure, the patient experienced a first headache.The first headache was resolved the next day with no residual effects.Two days post-procedure, the patient experienced a second headache.The second headache was ongoing.Post procedure, at 2-month, 6-month, and 12-month post-procedure the patient was neurologically assessed having a modified rankin scale (mrs) of 1.At 2-month, 6-month, and 12-month post-procedure the patient was assessed having a national institutes of health stroke scale (nihss) of 2.The physician has indicated that the 2 events of headache were possibly related to the index procedure and to the stent and not related to pre-existing condition/co-morbidity.However, it is unknown if the headache was related to the implanted coils and access devices (subject device).No further information is available.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, headache is a known risk associated with endovascular procedures and noted as in the clinical experience summary for neurovascular microcatheters.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the internal carotid artery-posterior communicating artery.On the day of the procedure, the patient experienced a first headache.The first headache was resolved the next day with no residual effects.Two days post-procedure, the patient experienced a second headache.The second headache was ongoing.Medication was administered to treat the headache (2mg dexamethasone and 1 mg morphine and 650 mg acetaminophen).Post procedure, at 2-month, 6-month, and 12-month post-procedure the patient was neurologically assessed having a modified rankin scale (mrs) of 1.At 2-month, 6-month, and 12-month post-procedure the patient was assessed having a national institutes of health stroke scale (nihss) of 2.The physician has indicated that the 2 events of headache were possibly related to the index procedure and to the stent and not related to pre-existing condition/co-morbidity.However, it is unknown if the headache was related to the implanted coils (subject devices) and access devices.No further information is available.

• 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
• 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 Key: 6932084
• MDR Text Key: 88932876
• Report Number: 3008881809-2017-00410
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: M0031681890
• Device Lot Number: 18835362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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): Other; Required Intervention
• Patient Age: 58 YR