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 2020-01-17 for AXIOS STENT AND DELIVERY SYSTEM M00553530 5353 manufactured by Boston Scientific Corporation.
[176834912]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. The exact date of the event is unknown. The provided event date, (b)(6) 2019, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 12/23/2019. (b)(4). Although expected, the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[176834913]
It was reported to boston scientific corporation that a hot axios stent was to be implanted transduodenal to the bile duct during an ultrasound-guided biliary drainage procedure performed on an unknown date. According to the complainant, during the procedure, the first flange of the stent began deploying further from the tip of the delivery system than the physician had experienced in previous stent placement procedures, and the first flange was deployed outside of the bile duct. The device was removed from the patient with the stent still partially deployed on the delivery system. The procedure was completed by placing another stent through the existing puncture site created during the attempted axios stent placement. There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00076 |
| MDR Report Key | 9604317 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2019-07-31 |
| Date Added to Maude | 2020-01-17 |
| 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 | 2020-01-17 |
| Model Number | M00553530 |
| Catalog Number | 5353 |
| Lot Number | 0024194209 |
| 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 | 2020-01-17 |