MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 3.5MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0350150

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

Patient Problems Intracranial Hemorrhage (1891); Vascular Dissection (3160); Ruptured Aneurysm (4436)

Event Date 08/11/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during percutaneous transluminal angioplasty (pta) and the stent implantation for stenosis of the proximal basilar artery procedure, the balloon catheter was used pre-pta, next the subject stent was implanted and post-dilation was performed using the balloon catheter.The procedure was completed successfully.Computes tomography (ct) showed an area where the strut of the subject stent was standing in the vessel wall.Next day, an aneurysm was formed and ruptured from the same area.For the ruptured aneurysm, additional surgery was performed with one coil and 2 other stents.The next day, an angiography was performed, which showed dissection of the vertebral artery, and the left vertebral artery was parent vessel embolized with a coil.The patient subsequently recovered.No additional information available.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed as the device was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that ruptured aneurysm and subarachnoid hemorrhage occurred the day after the surgery - the coil and stent implantation was performed - dissection of the vertebral artery occurred two days after the surgery, and the left vertebral artery was parent vessel embolized with a coil.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

Event Description

It was reported that during percutaneous transluminal angioplasty (pta) and the stent implantation for stenosis of the proximal basilar artery procedure, the balloon catheter was used pre-pta, next the subject stent was implanted and post-dilation was performed using the balloon catheter.The procedure was completed successfully.Computes tomography (ct) showed an area where the strut of the subject stent was standing in the vessel wall.Next day, an aneurysm was formed and ruptured from the same area.For the ruptured aneurysm, additional surgery was performed with one coil and 2 other stents.The next day, an angiography was performed, which showed dissection of the vertebral artery, and the left vertebral artery was parent vessel embolized with a coil.The patient subsequently recovered.

• Brand Name: WINGSPAN 3.5MM X 15MM - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17947525
• MDR Text Key: 325795651
• Report Number: 3008881809-2023-00509
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H050001
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003WE0350150
• Device Lot Number: 24061967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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: ENTERPRISE STENT (JOHNSON & JOHNSON).; GATEWAY BALLOON CATHETER (STRYKER).; LVIS STENT (MICROVENTION).; UNKNOWN COIL (UNKNOWN).
• Patient Outcome(s): Required Intervention; Other