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 11/22/2017

Event Type  Injury  

Manufacturer Narrative

This is the tenth of 10 reports.

Event Description

It was reported that the patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm.Post-procedure the patient was assessed having nihss and mrs of 0.It was reported that on one day post-procedure, the patient experienced headache.Medication (reopro 10mg) was administered.The headache is ongoing.According to the physician the headache was probably related to the procedure, possibly related to the stent, and possibly related to the implanted coils and/or the microcatheter (subject device).

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 such in the clinical experience summary for neurovascular microcatheters.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that the patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm.Post-procedure the patient was assessed having nihss and mrs of 0.It was reported that on one day post-procedure, the patient experienced headache.Medication (reopro 10mg) was administered.The headache is ongoing.According to the physician the headache was probably related to the procedure, possibly related to the stent, and possibly related to the implanted coils and/or the microcatheter (subject device).

• 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: 7156423
• MDR Text Key: 96110335
• Report Number: 3008881809-2018-00001
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: M0031681890
• Device Lot Number: 20046546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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
• Treatment: 9 TARGET COILS (STRYKER); NEUROFORM ATLAS STENT (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR