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 2020-01-07 for WALLFLEX BILIARY manufactured by Boston Scientific Corporation.
[178732374]
The complainant was unable to provide the suspect device upn and lot number; therefore, the expiration and manufacture dates are unknown. (b)(4). Report source: e7114 pocs in liver transplantation patients. The complainant indicated the stent remains implanted 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
[178732375]
It was reported to boston scientific corporation on december 13, 2019 that a wallflex biliary covered stent has been implanted in the common bile duct using a selective guidewire placement during a repeat endoscopic retrograde cholangiopancreatography (ercp) with balloon dilation procedure performed on (b)(6) 2019. Reportedly, the patient had previously been enrolled in the e7114 pocs in liver transplantation patients study clinical trial on (b)(6) 2018. According to the complainant, on (b)(6) 2019, a biliary reintervention was conducted. During the biliary reintervention, a repeat ercp with balloon dilation procedure was performed and a wallflex biliary covered stent was implanted. According to the complainant, the patient had experienced chest and abdominal pain after stent placement. Reportedly, the patient was hospitalized on (b)(6) 2019 and was discharged on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06380 |
| MDR Report Key | 9559794 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-07 |
| 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 BILIARY |
| Generic Name | BILIARY STENT SYSTEM FOR BENIGN STRICTURES |
| Product Code | PNB |
| Date Received | 2020-01-07 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-07 |