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 2020-03-09 for WALLFLEX BILIARY manufactured by Boston Scientific Corporation.
[188836000]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. The complainant was unable to provide the suspect device upn and lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). The complainant indicated that the device 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
[188836001]
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex biliary uncovered stent had been implanted during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed approximately eight months ago. Reportedly, the stent had been placed for palliative care of the patient. According to the complainant, the patient returned to the hospital in kidney failure, with jaundice and sepsis due to her late stage disease progression. On (b)(6) 2020, an endoscopic retrograde cholangiopancreatography (ercp) procedure was performed and the stent was found to be occluded. Sweeping with a biliary stone retrieval balloon was attempted to clear the stent, but it failed and another wallflex fully covered biliary stent was implanted inside the old stent with adequate drainage achieved. Reportedly, during the procedure, bleeding was noted from an esophageal laceration. Per thephysician, the tissue was very friable likely due to chemotherapy and overall condition of the patient. Hemostasis was achieved by placing a partially covered esophageal stent over the area and the procedure was completed. Reportedly, post procedure, the condition of the patient continued to worsen. The patient went into multiple organ failure and passed away within 24 hours of the procedure due to overwhelming sepsis and multi-organ failure. In the physician's assessment, the bleeding and patient's death were not related to the occluded stent but rather to the patient's overall poor condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00787 |
| MDR Report Key | 9808323 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-09 |
| 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 | BOSTON SCIENTIFIC CORPORATION |
| 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 | 2020-03-09 |
| 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 | 2020-03-09 |