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 2020-02-06 for AXIOS STENT AND DELIVERY SYSTEM manufactured by Boston Scientific Corporation.
[177967625]
Date of event was approximated to (b)(6) 2020 as no specific event date was reported. The complainant was unable to provide the suspect device upn and/or lot number. Therefore, the manufacture and expiration dates are unknown. According to the complainant, the suspect device is not available for return; 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
[177967626]
It was reported to boston scientific corporation on (b)(6) 2020 that a hot axios stent was used to treat a pancreatic cyst during a hot axios placement procedure performed on an unknown date. According to the complainant, the patient passed away. The date the patient passed away an the cause of the patient's death was not reported. Note: despite efforts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date. Should additional relevant details become available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00330 |
| MDR Report Key | 9676430 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-02-06 |
| 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. Death | 2020-02-06 |