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

Catalog Number UNK_NEU

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device remains in the patient.

Event Description

In a study to investigate ¿visualization of stent apposition after stent-assisted coiling of intracranial aneurysms using high resolution 3d fusion images acquired by c-arm ct¿ 75 patients with intracranial aneurysms were considered who received stent-assisted coiling with enterprise2, neuroform ez, or neuroform atlas stents confirmed by c-arm ct imaging at the institution between (b)(6) 2015 and (b)(6) 2017.Out of a total of 75 cases, 26 used subject stents.A 3d digital subtraction angiography scan for vessel imaging followed by a high-resolution cone beam ct scan for coil and stent imaging was performed.The study investigated malapposition of the stent trunk and stent edges.Of the 26 cases that used subject stents, 2 had malapposition against the stent trunk and 15 had malapposition against the stent edges.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 reports that this complaint was raised due to a study undertaken to investigate visualization of stent apposition after stent-assisted coiling of intracranial aneurysms using high resolution 3d fusion images acquired by c-arm ct between june 2015 and november 2017.Out of a total of 75 cases, 26 used subject stents.A 3d digital subtraction angiography scan for vessel imaging followed by a high-resolution cone beam ct scan for coil and stent imaging was performed.The study investigated malapposition of the stent trunk and stent edges.Of the 26 cases that used the subject stents, 2 had malapposition against the stent trunk and 15 had malapposition against the stent edges.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported event of the stent failed/unable to open.

Event Description

In a study to investigate ¿visualization of stent apposition after stent-assisted coiling of intracranial aneurysms using high resolution 3d fusion images acquired by c-arm ct¿ 75 patients with intracranial aneurysms were considered who received stent-assisted coiling with enterprise2, neuroform ez, or neuroform atlas stents confirmed by c-arm ct imaging at the institution between june 2015 and november 2017.Out of a total of 75 cases, 26 used subject stents.A 3d digital subtraction angiography scan for vessel imaging followed by a high-resolution cone beam ct scan for coil and stent imaging was performed.The study investigated malapposition of the stent trunk and stent edges.Of the 26 cases that used subject stents, 2 had malapposition against the stent trunk and 15 had malapposition against the stent edges.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.

• 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: 16994572
• MDR Text Key: 315867309
• Report Number: 3008881809-2023-00265
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 08/03/2023
• 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