MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-21 for NEUROFORM 3 EZ 4.0MM X 20MM - CE M003EN3E40200 manufactured by Stryker Neurovascular Cork.
[180619271]
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release. The device was returned and the reported lot number was confirmed from the returned packaging. Visual analysis revealed that the introducer sheath was kinked at 4 cm from the distal end, the sdw was kinked at 5 cm from the distal end, and the partial stent was returned and was noted broken/ fractured during use inside the patient's anatomy. Functional analysis could not be performed as the device components were not returned assembled. 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. Additional information indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and the patient's anatomy was severely tortuous. The damage noted is indicative of the reported event. It is probable that the sdw and the stent were damaged as a result of the difficulty experienced to advance within the microcatheter. An assignable case of procedural factors will be assigned to the as reported stent difficult/unable to advance or pullback through catheter and the as analysed stent broken/fractured during use/indie patient 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.
Patient Sequence No: 1, Text Type: N, H10
[180619272]
The subject stent was returned for analysis and it was discovered that the subject stent was broken/ fractured inside the patient's anatomy during the procedure. It was reported that the physician replaced the stent with another one in same type and completed the procedure successfully. There were no reported clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00047 |
| MDR Report Key | 9740827 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-04-23 |
| Date Added to Maude | 2020-02-21 |
| 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 Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROFORM 3 EZ 4.0MM X 20MM - CE |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2020-01-06 |
| Catalog Number | M003EN3E40200 |
| Lot Number | 21383643 |
| 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 IE NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |