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 2019-03-26 for WALLFLEX BILIARY M00570370 7037 manufactured by Boston Scientific Corporation.
[139903419]
Lot #, manufacture date: the complainant was unable to provide the suspect device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). The complainant indicated that the stent is not available for return as it had passed from the patient and could not be found; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[139903420]
It was reported to boston scientific corporation on march 04, 2019 that a wallflex biliary rx fully covered rmv stent was implanted to treat a malignant distal stricture in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2017. Reportedly, the patient's anatomy was not dilated prior to stent placement. According to the complainant, on (b)(6) 2019, the patient came back to the hospital with a dilated cbd and presented with epigastric pain. The physician performed magnetic resonance imaging (mri) and a computed tomography of kidneys, ureters and bladder (ct kub) scan and confirmed that the stent was no longer in the patient. Reportedly, the stent completely migrated and passed out of the patient; however the stricture had not resolved. The stent will be replaced with another stent at a future date. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01468 |
| MDR Report Key | 8453559 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-04 |
| Date Added to Maude | 2019-03-26 |
| 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 | 2019-03-26 |
| Model Number | M00570370 |
| Catalog Number | 7037 |
| 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 | 2019-03-26 |