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

Catalog Number UNK_NEU

Device Problem Structural Problem (2506)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2012

Event Type  Injury  

Manufacturer Narrative

The device is implanted in the patient.

Event Description

In a study aimed to report initial experience, technical considerations, and treatment outcomes using the subject stent delivery system in combination with coil embolization, seventeen consecutive patients harboring 21 wide-necked saccular cerebral aneurysms were treated with stent reconstruction between june 2010 and september 2010.In all cases, the subject stents were delivered and positioned without difficulty in deployment.Technical complications occurred in 4 patients, but none were directly related to the subject stent delivery system.In case 8, after deployment of a subject stent across the neck of a carotid ophthalmic artery aneurysm and carotid cavernous aneurysm, coil packing of the two separate aneurysms through the stent initially resulted in partial prolapse of coil mass into the parent vessel.A second stent was placed successfully.Post-procedure angiography demonstrated no parent vessel compromise in these two cases, nor were there any clinical sequelae.Arteries with segmental wall defects usually will require aneurysms to be treated with overlapping stents to reconstruct anatomy and avoid coil prolapse.Retreatment was performed for the three aneurysms with residual filling during follow up after subject stent implantation procedure.Two of these had further coiling for coil compaction without complication; follow-up angiography of these retreatments is pending.The third patient also had further coiling for compaction inside a particularly challenging partially thrombosed large wide-neck aneurysm; there was continued residual filling on his subsequent follow-up.A third procedure involving non-subject stent was performed on this patient which was complicated by a late intracerebral hemorrhage despite raymond class 1 occlusion on post-intracranial hemorrhage angiography.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

Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing 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.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to the stent does not support coil mass.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 the aneurysm recentralization requiring retreatment.

Event Description

In a study aimed to report initial experience, technical considerations, and treatment outcomes using the subject stent delivery system in combination with coil embolization, seventeen consecutive patients harboring 21 wide-necked saccular cerebral aneurysms were treated with stent reconstruction between june 2010 and september 2010.In all cases, the subject stents were delivered and positioned without difficulty in deployment.Technical complications occurred in 4 patients, but none were directly related to the subject stent delivery system.In case 8, after deployment of a subject stent across the neck of a carotid ophthalmic artery aneurysm and carotid cavernous aneurysm, coil packing of the two separate aneurysms through the stent initially resulted in partial prolapse of coil mass into the parent vessel.A second stent was placed successfully.Post-procedure angiography demonstrated no parent vessel compromise in these two cases, nor were there any clinical sequelae.Arteries with segmental wall defects usually will require aneurysms to be treated with overlapping stents to reconstruct anatomy and avoid coil prolapse.Retreatment was performed for the three aneurysms with residual filling during follow up after subject stent implantation procedure.Two of these had further coiling for coil compaction without complication; follow-up angiography of these retreatments is pending.The third patient also had further coiling for compaction inside a particularly challenging partially thrombosed large wide-neck aneurysm; there was continued residual filling on his subsequent follow-up.A third procedure involving non-subject stent was performed on this patient which was complicated by a late intracerebral hemorrhage despite raymond class 1 occlusion on post-intracranial hemorrhage angiography.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: 16994438
• MDR Text Key: 315867097
• Report Number: 3008881809-2023-00264
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020002/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 07/05/2023
• 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
• Treatment: UNKNOWN COILS
• Patient Outcome(s): Other; Required Intervention