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); Thrombosis/Thrombus (4440)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

This is report 1 of 2.The device is implanted in the patient.

Event Description

In a retrospective study aimed to provide a comparison of the atlas and neuroform ez stents in patients treated with stent-assisted coiling, consecutive patients with cerebral aneurysms treated with sac (stent-assisted coiling) between (b)(6) 2015 and (b)(6) 2019 at a single institution were identified.Outcomes included angiographic occlusion per the raymond¿roy (rr) scale, recanalization, retreatment and procedural complications.75 patients with 77 aneurysms treated with sac using the subject stent were identified.One patient had a small thrombus that had formed on the stent involving the a1-a2 junction; this completely resolved after administration of intraarterial eptifibatide (patient had a poor neurological exam given presentation with high-grade subarachnoid hemorrhage, but presumably she did not have new neurological deficits from this event).One patient developed a thrombus in the left anterior cerebral artery following stent placement.This was treated with intravenous abciximab with marked improvement in flow and resolution of the thrombus; patient woke up and remained without new neurological deficits.One patient developed an in-stent thrombus near the completion of the procedure.This resolved after administration of iv abciximab; patient had no new neurological deficits.Immediate rr1 aneurysm occlusion was achieved in 50 aneurysms (67.6%), while 16 aneurysms (21.6%) had a rr2 and 8 aneurysms (10.8%) had a rr3.In 71 aneurysms that had angiographic follow-up (95.6%), rr1 occlusion was obtained in 48 aneurysms (67.6%), rr2 in 11 aneurysms (15.5%), and rr3 in 12 aneurysms (16.9%).Nine aneurysms (12.7%) had recanalized, whereas 5 aneurysms had improved from rr3 to rr1 or rr2 on follow up angiography.Ten of the recurrent aneurysms (14.1%) have been retreated with rr1 in 4 patients, rr2 in 3 patients, and rr3 in 3 patients at the latest follow-up.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.

Event Description

In a retrospective study aimed to provide a comparison of the atlas and neuroform ez stents in patients treated with stent-assisted coiling, consecutive patients with cerebral aneurysms treated with sac (stent-assisted coiling) between (b)(6) 2015 and (b)(6) 2019 at a single institution were identified.Outcomes included angiographic occlusion per the raymond¿roy (rr) scale, recanalization, retreatment and procedural complications.75 patients with 77 aneurysms treated with sac using the subject stent were identified.One patient had a small thrombus that had formed on the stent involving the a1-a2 junction; this completely resolved after administration of intraarterial eptifibatide (patient had a poor neurological exam given presentation with high-grade subarachnoid hemorrhage, but presumably she did not have new neurological deficits from this event).One patient developed a thrombus in the left anterior cerebral artery following stent placement.This was treated with intravenous abciximab with marked improvement in flow and resolution of the thrombus; patient woke up and remained without new neurological deficits.One patient developed an in-stent thrombus near the completion of the procedure.This resolved after administration of iv abciximab; patient had no new neurological deficits.Immediate rr1 aneurysm occlusion was achieved in 50 aneurysms (67.6%), while 16 aneurysms (21.6%) had a rr2 and 8 aneurysms (10.8%) had a rr3.In 71 aneurysms that had angiographic follow-up (95.6%), rr1 occlusion was obtained in 48 aneurysms (67.6%), rr2 in 11 aneurysms (15.5%), and rr3 in 12 aneurysms (16.9%).Nine aneurysms (12.7%) had recanalized, whereas 5 aneurysms had improved from rr3 to rr1 or rr2 on follow up angiography.Ten of the recurrent aneurysms (14.1%) have been retreated with rr1 in 4 patients, rr2 in 3 patients, and rr3 in 3 patients at the latest follow-up.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, functional testing as well as visual 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 event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.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 as reported 'patient vessel thrombosis' and 'aneurysm recanalization requiring retreatment'.

• 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: 17003940
• MDR Text Key: 315946728
• Report Number: 3008881809-2023-00268
• 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: Other,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

• Date FDA Received: 05/25/2023
• 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: 07/10/2023
• 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