MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-16 for F/G WINGSPAN STENT SYSTEM 3.0 X 15MM M003WE0300150 manufactured by Stryker Neurovascular Cork.
[176664304]
The device history record confirms that the device met all material, assembly and performance specifications. Visual inspection was performed on the returned sample and it was observed the proximal end of the stabilizer/ hub was kinked and fractured, the stent was partially deployed from the delivery catheter and the delivery catheter shaft was noted to be flattened along the entire shaft length. Functional testing revealed that the delivery catheter was flushed, and the stabilizer was advanced to deploy the stent without difficulty. There were no anomalies noted to the deployed stent. The distal tapered tip was cut in order to remove the stabilizer, the stabilizer was removed from the catheter without difficulty. There were no further anomalies noted to the stabilizer. The device was stated to be in good condition and was prepared according to the dfu specifications. The reported issue is covered in the device directions for use. 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. The reported event was confirmed. It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore assignable cause of procedural factors will be assigned to reported issue.
Patient Sequence No: 1, Text Type: N, H10
[176664305]
Analysis of the returned device found the stent was partially deployed and the proximal end of the stabilizer was broken from the device. There were no clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00007 |
| MDR Report Key | 9596624 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-09-29 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2019-02-26 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TARA LOPEZ |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | STRYKER NEUROVASCULAR CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE MODEL FARM ROAD |
| Manufacturer City | CORK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F/G WINGSPAN STENT SYSTEM 3.0 X 15MM |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-01-16 |
| Returned To Mfg | 2019-11-08 |
| Catalog Number | M003WE0300150 |
| Lot Number | 21264353 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER NEUROVASCULAR CORK |
| Manufacturer Address | IDA INDUSTRIAL ESTATE MODEL FARM ROAD CORK NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |