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 04/22/2016

Event Type  Injury  

Manufacturer Narrative

This is 12 of 12 emdr reports filed for this event (9 coils and 3 microcatheters).The subject device is not available.

Event Description

It was reported that during the stent assisted coil embolization procedure, the patient experienced headache which resolved without residual effect the next day.Post procedure the patient was assessed having a mrs of 0.Also, the aneurysm occlusion status post procedure was assessed as complete obliteration, no opacification of the aneurysm or neck, (leaving neck to preserve branch is considered modified class i).The study facility assessed the headache as being possibly related to the stent and procedure; however, unknown to the implanted coils and microcatheters (subject device).During follow up visits at 2, 6, and 12 months post the index procedure, the patient was assessed having a mrs of 0.No further information is available.

Manufacturer Narrative

A review of the device history record could not be performed because the lot number was not reported and it could not be obtained.The subject device is not available; therefore, physical as well as a functional evaluation could not be performed.However, headache is a known complication noted in the clinical experience summary for neurovascular microcatheters.Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

It was reported that during the stent assisted coil embolization procedure, the patient experienced headache which resolved without residual effect the next day.Post procedure the patient was assessed having a mrs of 0.Also, the aneurysm occlusion status post procedure was assessed as complete obliteration, no opacification of the aneurysm or neck, (leaving neck to preserve branch is considered modified class i).The study facility assessed the headache as being possibly related to the stent and procedure; however, unknown to the implanted coils and microcatheters (subject device).During follow up visits at 2, 6, and 12 months post the index procedure, the patient was assessed having a mrs of 0.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: 6933477
• MDR Text Key: 88939363
• Report Number: 3008881809-2017-00424
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013789
• 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: 12/03/2017

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 Catalogue Number: M0031681890
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• 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): Other
• Patient Age: 49 YR