MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-04 for NEUROFORM 3 EZ 4.5MM X 30MM - CE M003EN3E45300 manufactured by Stryker Neurovascular Cork.
[177811380]
It was reported that during the procedure, when a previously placed coil was half inserted into the aneurysm, deployment of the subject stent was attempted. However, when withdrawing the stent delivery wire, the stent distal bumper got stuck at distal aspect of subject stent. The physician attempted to adjust the stent but this caused it to migrate a lot inside the patient anatomy and loose targeted position. The stent delivery wire was withdrawn causing an associated catheter to migrate out of the aneurysm and coil to be stretched and fractured. The physician tried to adjust the stent delivery wire and micro catheter but was unable and finally took the stent delivery wire out and the procedure was stopped. Based on additional information received, it was reported that the patient developed muscle weakness and was under temporary medication. It was also reported that the subject stent was still inside the patient's body. The procedure was not completed successfully and no further information is currently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00031 |
| MDR Report Key | 9668893 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-04 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-05-23 |
| Date Added to Maude | 2020-02-04 |
| 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 4.5MM X 30MM - CE |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-02-04 |
| Returned To Mfg | 2020-01-27 |
| Catalog Number | M003EN3E45300 |
| Lot Number | 21464263 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other; 2. Required No Informationntervention | 2020-02-04 |