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

Catalog Number M0031681890

Device Problem Peeled/Delaminated (1454)

Patient Problems Embolus (1830); Seizures (2063); Device Embedded In Tissue or Plaque (3165)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

This is the 1st of 2 reports.Subject device is not available.

Event Description

It was reported that the patient underwent uneventful coil embolization to treat the internal carotid artery (ica) with the microcatheter (subject device) and the occlusion balloon catheter.One (1) month post-procedure, the patient developed convulsive seizure.Unspecified medical treatment was performed and the adverse event was resolved without any sequelae.The patient was discharged approximately 3 weeks post-adverse event.In the physician's opinion, there is a possibility that the subject device or the balloon occlusion catheter coating polymer peeled off and migrated to the distal artery possibly causing the convulsive seizure.

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; review and analysis of all available information failed to indicate an assignable cause or probable assignable cause for the reported event.In this case it is possible that the inner liner of the microcatheter got damaged while pushing the guide wire/coil against friction which consequently led to the reported issue; this however cannot be proven.It was reported that: ¿in the physician's opinion, there is a possibility that sl10's or transform's coating polymer was peeled off and migrated to distal artery and then the polymer might cause the convulsive seizure¿.Based on the information available the exact cause for the reported event cannot be determined.

Event Description

It was reported that the patient underwent uneventful coil embolization to treat the internal carotid artery (ica) with the microcatheter (subject device) and the occlusion balloon catheter.One (1) month post-procedure, the patient developed convulsive seizure.Unspecified medical treatment was performed and the adverse event was resolved without any sequelae.The patient was discharged approximately 3 weeks post-adverse event.In the physician's opinion, there is a possibility that the subject device or the balloon occlusion catheter coating polymer peeled off and migrated to the distal artery possibly causing the convulsive seizure.

• 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: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6219948
• MDR Text Key: 63775253
• Report Number: 3008881809-2017-00003
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)180731(10)19193094
• Combination Product (y/n): N
• PMA/PMN Number: K013789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: M0031681890
• Device Lot Number: 19193094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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
• Treatment: TRANSFORM BALLOON CATHETER ( STRYKER)
• Patient Outcome(s): Other; Required Intervention