MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number UNK_NEU

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

Patient Problems Aneurysm (1708); Stenosis (2263)

Event Date 02/01/2021

Event Type  Injury  

Event Description

In a study to investigate "clinical outcomes after stent-assisted coiling with 3 types of self-expanding laser-cut stents in patients with wide-necked intracranial aneurysms", 364 patients were included in the study between july 2010 and september 2019.Patients selected had undergone imaging follow-up, investigated aneurysm and stent features, stent-related complications, recanalization and retreatment.Out of a total of 364 cases, 105 cases used stent (subject device) and of these 105 cases, 13 patients had recanalization and 9 patients required retreatment.Most retreatments were performed by adding coils with the transcell technique.One retreatment of stent-assisted coiling by deploying an additional stent into the original subject stent, 1 retreatment by inserting a flow diverter into the original subject stent, and 1 retreatment of parent artery occlusion were performed.No further information is available.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints, if any.

Manufacturer Narrative

H3 other text : the device remains in the patient.

Event Description

In a study to investigate "clinical outcomes after stent-assisted coiling with 3 types of self-expanding laser-cut stents in patients with wide-necked intracranial aneurysms", 364 patients were included in the study between july 2010 and september 2019.Patients selected had undergone imaging follow-up, investigated aneurysm and stent features, stent-related complications, recanalization and retreatment.Out of a total of 364 cases, 105 cases used stent (subject device) and of these 105 cases, 13 patients had recanalization and 9 patients required retreatment.Most retreatments were performed by adding coils with the transcell technique.One retreatment of stent-assisted coiling by deploying an additional stent into the original subject stent, 1 retreatment by inserting a flow diverter into the original subject stent, and 1 retreatment of parent artery occlusion were performed.No further information is available.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints, if any.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.The event description states in a study to investigate "clinical outcomes after stent-assisted coiling with 3 types of self-expanding laser-cut stents in patients with wide-necked intracranial aneurysms", 364 patients were included in the study between july 2010 and september 2019.Patients selected had undergone imaging follow-up, investigated aneurysm and stent features, stent-related complications, recanalization and retreatment.Out of a total of 364 cases, 105 cases used stent (subject device) and of these 105 cases, 13 patients had recanalization and 9 patients required retreatment.Most retreatments were performed by adding coils with the transcell technique.One retreatment of stent-assisted coiling by deploying an additional stent into the original subject stent, 1 retreatment by inserting a flow diverter into the original subject stent, and 1 retreatment of parent artery occlusion were performed.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.Therefore, a probable cause of anticipated procedural complication was assigned to the as reported aneurysm recanalization requiring treatment, patient parent vessel stenosis, and aneurysm recanalization no treatment required.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• 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: 17019509
• MDR Text Key: 316119661
• Report Number: 3008881809-2023-00274
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020002/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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: 07/18/2023
• 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): Required Intervention; Other