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 2019-02-04 for WALLFLEX DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM M00555870 5587 manufactured by Boston Scientific Corporation.
[134855698]
The complainant was unable to provide the suspect device lot number. Therefore, the manufacture and expiration dates are unknown. (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
[134855699]
It was reported to boston scientific corporation on january 10, 2019 that a wallflex duodenal soft uncovered stent was implanted in the duodenum to treat a stenosis due to pancreatic cancer during a stent placement procedure performed on (b)(6) 2018. According to the complainant, on (b)(6) 2018, the stent was successfully implanted; the proximal side of the stent was in the stomach and the distal end did not reach the papilla. A computed tomography (ct) scan was performed and showed the entire stenosis was covered, and no problem was observed. According to the complainant, the patient could eat a 5 minute meal porridge several days after stent placement. However, it was reported that ascites puncture was necessary to perform every day. On (b)(6) 2018, anemia developed and the patient received blood transfusion. On (b)(6) 2018, patient's hemoglobin count improved and the anemia stopped. On (b)(6) 2018, patient's hemoglobin count decreased and the anemia redeveloped. Symptoms of abdominal pain were also noticed but observation using an endoscope could not be performed due to the patient condition. On (b)(6) 2018, the patient passed away. On january 10, 2019 , an autopsy report was reported and it was found that the stomach was perforated with the proximal stump of the duodenal stent, and the contents inside the stomach leaked into the abdominal cavity. The cause of death was shock due to peritonitis. Per the physician, the patient's condition was not really good, and even if the duodenal stent was not inserted, there will still be a high possibility that the patient will die.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00452 |
| MDR Report Key | 8300809 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-04 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-02-04 |
| 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 DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM |
| Generic Name | STENT,METALLIC,EXPANDABLE,DUODENAL |
| Product Code | MUM |
| Date Received | 2019-02-04 |
| Model Number | M00555870 |
| Catalog Number | 5587 |
| 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. Death; 2. Required No Informationntervention | 2019-02-04 |