MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number UNK_NEU

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

Patient Problem Headache (1880)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

This is the first of 6 reports.Subject device remains implanted.

Event Description

It was reported that the patient underwent successful stent-assisted coil embolization of an aneurysm located at the basilar apex with the subject coils.Post-procedure, the patient experienced headache that is still ongoing.Twenty-four hours post procedure the patient neurological assessment mrs was 0.Medication (unspecified) was administered.According to the physician, the headache was probably related to the procedure and unrelated to the stent.It was unknown if the headache was related to the implanted coils (subject device) or microcatheters.

Manufacturer Narrative

A device history record (dhr) could not be performed because the lot remains unknown.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 device directions for use (dfu).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 aneurysm located at the basilar apex with the subject coils.Post-procedure, the patient experienced headache that is still ongoing.24 hours post procedure the patient neurological assessment mrs was 0.Medication (unspecified) was administered.According to the physician, the headache was probably related to the procedure and unrelated to the stent.It was unknown if the headache was related to the implanted coils (subject device) or microcatheters.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 7149794
• MDR Text Key: 95896657
• Report Number: 3008881809-2017-00542
• Device Sequence Number: 1
• Product Code: HCG
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• 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; Required Intervention
• Patient Age: 49 YR