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 Problem Aneurysm (1708)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

This is report 2 of 2.H3 other text : 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 january 2015 and june 2019 at a single institution were identified.Outcomes included angiographic occlusion per the raymond¿roy (rr) scale, recanalization, retreatment and procedural complications.72 patients with 77 aneurysms treated with sac using the subject stent were identified.On immediate angiographic analysis, rr1 aneurysm occlusion was obtained in 63 aneurysms (81.8%), while 14 aneurysms had a rr2 (18.2%) and no aneurysms had a rr grade 3 (rr3) (0%).In 43 aneurysms that had angiographic follow-up (55.8%), rr1 was obtained in 36 aneurysms (83.7%), rr2 in 4 aneurysms (9.3%) and rr3 in 3 aneurysms (7%).The aneurysms with rr3 had all recanalized (7% of aneurysms with angiographic follow-up).Two of the recurrent aneurysms have been retreated with recoiling with rr1 occlusion on the latest follow-up (4.6% of aneurysms with angiographic 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 january 2015 and june 2019 at a single institution were identified.Outcomes included angiographic occlusion per the raymond¿roy (rr) scale, recanalization, retreatment and procedural complications.72 patients with 77 aneurysms treated with sac using the subject stent were identified.On immediate angiographic analysis, rr1 aneurysm occlusion was obtained in 63 aneurysms (81.8%), while 14 aneurysms had a rr2 (18.2%) and no aneurysms had a rr grade 3 (rr3) (0%).In 43 aneurysms that had angiographic follow-up (55.8%), rr1 was obtained in 36 aneurysms (83.7%), rr2 in 4 aneurysms (9.3%) and rr3 in 3 aneurysms (7%).The aneurysms with rr3 had all recanalized (7% of aneurysms with angiographic follow-up).Two of the recurrent aneurysms have been retreated with recoiling with rr1 occlusion on the latest follow-up (4.6% of aneurysms with angiographic 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 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.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 as reported ¿aneurysm recanalization requiring treatment.¿.

• 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: 17003939
• MDR Text Key: 315946698
• Report Number: 3008881809-2023-00269
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180031
• 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: 08/14/2023

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: 07/21/2023
• 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): Other; Required Intervention