MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-09 for WALLFLEX ESOPHAGEAL M00516910 56453 manufactured by Boston Scientific Corporation.
[174519802]
(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
[174519803]
It was reported to boston scientific corporation on december 13, 2019 that a wallflex esophageal partially covered stent was implanted to treat a 1. 5 cm distal esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2019. Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement. Additionally 2-3 weeks later, the patient wanted the stent removed due to severe discomfort. According to the complainant, during the stent removal procedure, the physician had difficulty removing the stent from the patient due to normal tissue ingrowth. Reportedly, during the attempt removal, the stent retrieval loop broke and the stent was unable to be removed. The physician placed a fully covered stent within the initial stent and planned to remove the stent from the patient in a couple of weeks. On (b)(6) 2019, the stent was successfully removed using forceps. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06455 |
| MDR Report Key | 9572144 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| Model Number | M00516910 |
| Catalog Number | 56453 |
| Lot Number | 0024596790 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-09 |