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 2020-02-26 for AXIOS M00553650 50270 manufactured by Boston Scientific Corporation.
[188831132]
(b)(6). (b)(4). The complainant indicated that the device was disposed 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 medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188831133]
It was reported to boston scientific corporation on (b)(6) 2020 that a hot axios stent was to be implanted in a transgastric position to treat a pancreatic pseudocyst during a pancreatic cyst drainage procedure performed on (b)(6) 2020. Reportedly, the physician was using the eus method of deployment where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1:1 fashion. According to the complainant, during the procedure, puncture was performed using an fna needle and the guidewire was placed in the cyst. The axios stent was advanced along the guidewire and the first flange was deployed on the cyst side. The delivery system was pulled up to the stomach wall and the second flange was deployed in the scope. Reportedly, the physician had trouble releasing the second flange out from the scope; the delivery system was pushed several times and after distance was obtained, the flange was able to be deployed. Cyst fluid was found to be leaking into the stomach. When the fluoroscopic image was reviewed, it was confirmed that the stent had moved out from its original position into the anal side inside the cyst. The guidewire remained providing access to the cyst, and a second axios stent of 20mm size was placed to complete the procedure. On (b)(6) 2020, fistula was dilated using a cre 15mm balloon catheter and the scope was inserted into the cyst. The migrated stent was then successfully removed using a grasping forceps. Reportedly, the recorded eus video of the placement procedure was reviewed and it was confirmed that the stent was deployed into the cyst side at the same time when the delivery system was pushed. There were no patient complications reported from the first placement up to the retrieval of the stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00536 |
| MDR Report Key | 9759434 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-11-20 |
| Date Added to Maude | 2020-02-26 |
| 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 | 2020-02-26 |
| Model Number | M00553650 |
| Catalog Number | 50270 |
| Lot Number | 0024798877 |
| 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 | 2020-02-26 |