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 M00553650 5365 manufactured by Boston Scientific Corporation.
[188207732]
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown. However, the complainant reported that the device was not expired. (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
[188207733]
It was reported to boston scientific corporation that a hot axios stent was to be implanted transgastric to the pancreas to treat a walled-off necrosis (won) during a won drainage procedure performed on (b)(6) 2019. Reportedly, the patient's won was approximately 25cm in size. According to the complainant, during the procedure, after the first flange was released inside the won, the first flange did not fully expand due to the presence of necrotic tissue. After approximately 10 minutes, the first flange was only slightly expanded. The physician deployed the second flange of the stent in the stomach. The first flange of the stent was still not fully expanded inside the won, and the physician attempted to expand the stent using forceps, but the first flange of the stent moved out of the won and into the stomach. The axios stent was removed from the patient using forceps, and a double pigtail stent was placed to complete the procedure. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00087 |
| MDR Report Key | 9604378 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2019-12-25 |
| 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 |
| Generic Name | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE |
| Product Code | PCU |
| Date Received | 2020-01-17 |
| Model Number | M00553650 |
| Catalog Number | 5365 |
| 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 |