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 Stenosis (2263)

Event Date 03/11/2019

Event Type  Death  

Manufacturer Narrative

The device is implanted in the patient.

Event Description

In a study aimed to compare acute ischemic stroke (ais) patients with an occlusion of the m1 segment due to an underlying stenosis (group 1) and patients with embolic m1 occlusions without underlying stenosis (group 2) undergoing endovascular recanalization in a large-volume center in europe, a total of 533 (mean age 74 ranging from 63 to 82) consecutive acute stroke patients with an isolated m1 occlusion who underwent stent retriever mechanical thrombectomy between 02/2010 and 08/2017 were included.Underlying intracranial atherosclerotic stenosis (icas) was present in 10 patients (1.9%), whereas 523 patients (98.1%) had an embolic occlusion without stenosis.All patients underwent endovascular thrombectomy (evt) - if presence of wall irregularities in the treated vessel greater than 50% of the original vessel lumen, 2 mg nimodipine was added, 10 min later in case of regression it was considered a vasospasm, when they persisted an underlying icas was suspected.If re-occlusion occurred, the thrombectomy was repeated.When stenosis persisted, percutaneous transluminal angioplasty (pta) was performed with a non-compliant balloon.10min later when stenosis persisted or re-occlusion occurred stent implantation was performed.If thrombus formation occurred within the stent, a glycoprotein iib/iiia antagonist was slowly injected intra-arterially.Follow-up angiography was performed 10¿20 min after stent deployment and if no change or thrombus formation was observed, the procedure was terminated.Among 10 patients with icas, patient#9 had nihss-36, pre morbid mrs-1 with mental retardation, 1 retrieval attempt was made, immediate mtici-1, mtici after stent-1, 300 mg asa was given, mrs 6 at 90 days, subject stent occluded on follow up.No further information is available.

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.It cannot be confirmed if the device met specification, as the device was not returned.The source of these complaints was from a literature article review.Good faith efforts have been exhausted in response to a request for further information.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.Patient death and patient parent vessel stenosis are documented in the wingspan dfu/clinical experience summary as anticipated outcomes of these types of procedures.An assignable cause of anticipated procedural complication, will be assigned to the reported patient death and patient parent vessel stenosis, 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 with the directions for use, product labeling and/or risk documentation files.

Event Description

In a study aimed to compare acute ischemic stroke (ais) patients with an occlusion of the m1 segment due to an underlying stenosis (group 1) and patients with embolic m1 occlusions without underlying stenosis (group 2) undergoing endovascular recanalization in a large-volume center in europe, a total of 533 (mean age 74 ranging from 63 to 82) consecutive acute stroke patients with an isolated m1 occlusion who underwent stent retriever mechanical thrombectomy between (b)(6) 2010 and (b)(6) 2017 were included.Underlying intracranial atherosclerotic stenosis (icas) was present in 10 patients (1.9%), whereas 523 patients (98.1%) had an embolic occlusion without stenosis.All patients underwent endovascular thrombectomy (evt) - if presence of wall irregularities in the treated vessel greater than 50% of the original vessel lumen, 2 mg nimodipine was added, 10 min later in case of regression it was considered a vasospasm, when they persisted an underlying icas was suspected.If re-occlusion occurred, the thrombectomy was repeated.When stenosis persisted, percutaneous transluminal angioplasty (pta) was performed with a non-compliant balloon.10min later when stenosis persisted or re-occlusion occurred stent implantation was performed.If thrombus formation occurred within the stent, a glycoprotein iib/iiia antagonist was slowly injected intra-arterially.Follow-up angiography was performed 10¿20 min after stent deployment and if no change or thrombus formation was observed, the procedure was terminated.Among 10 patients with icas, patient#9 had nihss-36, pre morbid mrs-1 with mental retardation, 1 retrieval attempt was made, immediate mtici-1, mtici after stent-1, 300 mg asa was given, mrs 6 at 90 days, subject stent occluded on follow up.No further information is available.

• 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: 16212835
• MDR Text Key: 307765334
• Report Number: 3008881809-2023-00030
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: H050001
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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: 04/05/2023
• 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
• Patient Outcome(s): Other; Death