MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 4.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WS0400200

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/18/2014

Event Type  Injury  

Event Description

It was reported that during the procedure, the inner body dual tapered tip broke off inside of the patient.A stent had to be deployed to hold the broken tip in place.No additional information was provided.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The outer delivery catheter, inner catheter and rotating hemostatic valve were returned.Visual and microscopic examination revealed that the distal section of the inner catheter had detached/separated and was not returned.Blood was noted in the returned device.No other anomalies were noted.From the information provided and the investigation results, it was concluded that the device was damaged during use due to procedural factors/operational context.

Event Description

It was reported that during the procedure, the inner body dual tapered tip broke off inside of the patient.A stent had to be deployed to hold the broken tip in place.No additional information was provided.

• Brand Name: F/G WINGSPAN STENT SYSTEM 4.0 X 20MM
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: alyson harris ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 4126302
• MDR Text Key: 5072192
• Report Number: 3008853977-2014-00299
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: M003WS0400200
• Device Lot Number: 15180710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 09/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2012
• 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): Required Intervention