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 2020-01-31 for AXIOS STENT AND DELIVERY SYSTEM M00553550 5355 manufactured by Boston Scientific Corporation.
[188328729]
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) 2020, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2020. (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
[188328730]
It was reported to boston scientific corporation that a hot axios stent was implanted transgastric to the pancreas to treat a pancreatic fluid collection (pfc) during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2019. According to the complainant, during a necrosectomy procedure performed on a unknown date, while the physician was attempting to debride the pfc, the axios stent dislodged from the collection and migrated into the stomach. The stent was removed from the patient using rat tooth forceps. 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. Note: the stent was intended to be placed to treat a cyst with less than 70% liquid content; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00261 |
| MDR Report Key | 9655825 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-04-29 |
| Date Added to Maude | 2020-01-31 |
| 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 | 2020-01-31 |
| Model Number | M00553550 |
| Catalog Number | 5355 |
| Lot Number | 0023710379 |
| 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 | 2020-01-31 |