MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 4.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0400200

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

Patient Problems Muscle Weakness (1967); Dysphasia (2195)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

This is report 1 of 2.Device remains implanted in patient.

Event Description

It was reported that the patient was stented for a long artery dissection on right ica (internal carotid artery) c2 segment.The stent (subject device) was implanted smoothly and the procedure was completed successfully without any difficulties.Post procedure, the patient showed good recovery of the dissection site.However, one week post procedure, the patient got complete aphasia and grade 1 on left upper limb of muscle strength and grade 0 on left lower limb of muscle strength.The patient received conventional antiplatelet and anti-infection treatment for aphasia and muscle strength weakness.Ten days post procedure, the patient left the hospital without receiving further treatment.No further information is available.

Event Description

It was reported that the patient was stented for a long artery dissection on right ica (internal carotid artery) c2 segment.The stent (subject device) was implanted smoothly and the procedure was completed successfully without any difficulties.Post procedure, the patient showed good recovery of the dissection site.However, one week post procedure, the patient got complete aphasia and grade 1 on left upper limb of muscle strength and grade 0 on left lower limb of muscle strength.The patient received conventional antiplatelet and anti-infection treatment for aphasia and muscle strength weakness.Ten days post procedure, the patient left the hospital without receiving further treatment.No further information is available.

Manufacturer Narrative

The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.Based on the investigation results and available information an assignable cause of anticipated procedural complication was assigned to the as reported issue of patient muscle weakness and dysphasia since the issues are due to known physiological effects of the procedure and or/ patient condition noted with the direction for use, device labelling and/or risk documentation files.

• Brand Name: F/G WINGSPAN STENT SYSTEM 4.0 X 20MM
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8371252
• MDR Text Key: 137179044
• Report Number: 3008881809-2019-00055
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: M003WE0400200
• Device Lot Number: 20900549
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSEND GUIDEWIRE (STRYKER); TRANSEND GUIDEWIRE (STRYKER)
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 70