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

Catalog Number UNK_NEU

Device Problem Migration (4003)

Patient Problems Angina (1710); Stroke/CVA (1770); Myocardial Infarction (1969); Paresis (1998); Transient Ischemic Attack (2109); Hypoesthesia (2352); Paresthesia (4421)

Event Date 04/18/2023

Event Type  Death  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

The survey was conducted in germany, spain and united states.During 28 days follow-up, stent migration, tia (new focal neurological deficit of sudden onset, lasting less than 24 hours unassociated with a hemorrhage which confirmed on brain ct or mri), temporal diplopia, hemiparesis or nerve paresis, dysesthesia or other neurological symptoms, death due to a neurological event (stroke), angina pectoris, myocardial infarction was reported.No further information was provided.

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.He 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 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 death¿, ¿ patient tia (transient ischemic attack)¿, ¿patient stroke¿, ¿patient neurological deficit¿, ¿patient complications'.An assignable cause of procedural factors will be assigned to the as reported ¿stent dislodged/migrated¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

The survey was conducted in germany, spain and united states.During 28 days follow-up, stent migration, tia (new focal neurological deficit of sudden onset, lasting less than 24 hours unassociated with a hemorrhage which confirmed on brain ct or mri), temporal diplopia, hemiparesis or nerve paresis, dysesthesia or other neurological symptoms, death due to a neurological event (stroke), angina pectoris, myocardial infarction was reported.No further information was provided.

• 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: 16904619
• MDR Text Key: 314931821
• Report Number: 3008881809-2023-00238
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050001
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• 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: 06/30/2023
• 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): Death; Other