MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-24 for AXIOS STENT AND DELIVERY SYSTEM M00553520 5352 manufactured by Boston Scientific Corporation.
[176387514]
(b)(4). The complainant indicated that the device has been disposed of and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[176387515]
It was reported to boston scientific corporation that a hot axios stent was to be implanted transduodenal to the common bile duct (cbd) during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the second flange of the stent failed to deploy. Reportedly, the handle was rotated as the device was luer locked to the scope. The device was removed from the patient with the stent partially deployed on the delivery system. A second axios stent was placed to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00166 |
| MDR Report Key | 9629190 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2019-05-16 |
| Date Added to Maude | 2020-01-24 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIOS STENT AND DELIVERY SYSTEM |
| Generic Name | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE |
| Product Code | PCU |
| Date Received | 2020-01-24 |
| Model Number | M00553520 |
| Catalog Number | 5352 |
| Lot Number | 0023802697 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-24 |