MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Convulsion/Seizure (4406)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

This is 2 of 3 reports.The device is not available to the manufacturer.

Event Description

It was reported that 1.5 months post endovascular stent assisted coil embolization procedure of a cerebral aneurysm, patient was reported to have experienced focal motor seizer since the end of april.Mri of the brain performed on 17th june finally revealed a lesion, supplementary examined with contrast on 25th may, also showed contrast enhancement.Brain biopsy was performed to clarify the suspicion of a pathogen related vasculitis.Foreign body vasculitis was diagnosed and based on histopathological findings type of the foreign material was found to be filamentous.Exact determination of the foreign material has not yet made.It was not confirmed that the issue was caused by the subject coil.No additional 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 device was not returned for analysis.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.It was reported that an intracranial endovascular coil embolization assisted stenting procedure was performed in which the subject coil was used and post procedure, the patient was reported to have seizures.Mri of the brain revealed a lesion which was supplementally examined with contrast and showed contrast enhancement.A biopsy was performed and based on histopathological findings of "filamentous material", a diagnosis of "foreign body vasculitis" was given.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the patient's anatomy was moderately tortuous.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 and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.

Event Description

It was reported that 1.5 months post endovascular stent assisted coil embolization procedure of a cerebral aneurysm, patient was reported to have experienced focal motor seizer since the end of april.Mri of the brain performed on 17th june finally revealed a lesion, supplementary examined with contrast on 25th may, also showed contrast enhancement.Brain biopsy was performed to clarify the suspicion of a pathogen related vasculitis.Foreign body vasculitis was diagnosed and based on histopathological findings type of the foreign material was found to be filamentous.Exact determination of the foreign material has not yet made.It was not confirmed that the issue was caused by the subject coil.No additional information is available.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 12558015
• MDR Text Key: 274226219
• Report Number: 3008881809-2021-00408
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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: 12/29/2021
• 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: ECLIPSE BALLOON (BALT); GDC COILS (STRYKER); NEUROFORM STENT (STRYKER); TRAXCESS MICROWIRE (MICROVENTION); UNKNOWN DIAGNOSTIC CATHETERS (MERIT MEDICAL); UNKNOWN GUIDING CATHETER (CODMANN); VASCO MICROCATHETERS (BALT)
• Patient Outcome(s): Other