MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0300150

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly, and performance specifications.Visual and microscopic examination of the returned device found that the delivery catheter was noted to be extensively flattened and the stabilizer was broken at the proximal end.Functional testing could not be performed as the stabilizer could not be removed from the catheter.Based on the analysis, the reported event was confirmed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the investigation results and available information, it is possible that the anatomical factors present during the clinical procedure caused the damage to the device and the reported defects.Therefore, a cause of procedural factors has been assigned to this investigation.

Event Description

Based on the investigation the stent stabilizer was found to be broken inside patient.There were no clinical consequences to the patient.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.0 X 15MM
• 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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8837925
• MDR Text Key: 152542618
• Report Number: 3008881809-2019-00216
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2021
• Device Catalogue Number: M003WE0300150
• Device Lot Number: 21107873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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: DAC (STRYKER)
• Patient Age: 52 YR