MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

Device Problem Migration (4003)

Patient Problems Hyperplasia (1906); Stenosis (2263)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported that during follow up after 6-7 months post implantation with the subject flow diverter, the patient in the clinical study was found to have intimal hyperplasia and fish mouth deformation of proximal point of the subject flow diverter.The subject flow diverter was also noted to have moved a bit and changed anatomy of the curve.The patient was noted to have been doing fine.No other information is available.

Event Description

It was reported that during follow up after 6-7 months post implantation with the subject flow diverter, the patient in the clinical study was found to have intimal hyperplasia and fish mouth deformation of proximal point of the subject flow diverter.The subject flow diverter was also noted to have moved a bit and changed anatomy of the curve.The patient was noted to have been doing fine.No other information is available.Update: additional information received on 26-oct-2021, confirmed that the same reported event and product had already been entered and captured under (b)(4) and mdr (b)(4).Therefore, this event does not meet the criteria of a complaint and a redaction emdr will be filed due to duplicate submission.

Manufacturer Narrative

B5: executive summary - updated and corrected.Additional information received on 26-oct-2021, confirmed that the same reported event and product had already been entered and captured under (b)(4) and mdr: (b)(4).Therefore, this event does not meet the criteria of a complaint and a redaction emdr will be filed due to duplicate submission.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 12637199
• MDR Text Key: 276583463
• Report Number: 3008881809-2021-00436
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170024/S003
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• 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
• Patient Outcome(s): Other