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 2020-03-20 for WALLFLEX ESOPHAGEAL M00516700 1670 manufactured by Boston Scientific Corporation.
[188849481]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188849482]
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex esophageal fully covered stent was implanted to treat an approximately 7cm benign stricture in the mid esophagus during a stent placement procedure performed on (b)(6) 2020. Reportedly, the patient's anatomy was dilated prior to stent placement. According to the complainant, during the procedure the stent did not fully expand. X-ray was performed after 24 and 48 hours post stent placement procedure and the stent still did not expand. Reportedly, on (b)(6) 2020, the stent was removed and another wallflex esophageal stent was implanted to complete the procedure. There were no patient complications as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01048 |
| MDR Report Key | 9862736 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-03-05 |
| Date Added to Maude | 2020-03-20 |
| 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 | WALLFLEX ESOPHAGEAL |
| Generic Name | PROSTHESIS, ESOPHAGEAL |
| Product Code | ESW |
| Date Received | 2020-03-20 |
| Model Number | M00516700 |
| Catalog Number | 1670 |
| Lot Number | 0023438500 |
| 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 | 2020-03-20 |