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 2019-04-23 for WALLFLEX BILIARY manufactured by Boston Scientific Corporation.
[142868128]
The complainant was unable to report the suspect device upn and lot number; therefore manufacture and expiration dates are unknown. (b)(4). The complainant indicated that the device 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
[142868129]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary uncovered stent has been implanted to treat a stenosis as palliation for advanced cancer in the common bile duct during a procedure performed on an unknown date. Reportedly, the patient's anatomy was not dilated prior to initial stent placement. According to the complainant, on (b)(6) 2019, the patient presented with obstructive jaundice. An endoscopic retrograde cholangiopancreatography (ercp) procedure was performed and tumor ingrowth was noted inside the wallflex biliary uncovered stent. A plastic stent was placed through the stent and the procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02128 |
| MDR Report Key | 8541934 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-04-02 |
| Date Added to Maude | 2019-04-23 |
| 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 IRELAND LIMITED |
| 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 | 2019-04-23 |
| 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 | 2019-04-23 |