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 2020-01-17 for WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM manufactured by Boston Scientific Corporation.
[188208010]
The complainant was unable to report the suspect device upn and lot number; therefore, the manufacture and expiration dates are unknown. (b)(6). (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
[188208011]
It was reported to boston scientific corporation on december 23, 2019 that two overlapping wallflex colonic stents were implanted in the sigmoid colon and rectum during a colonoscopic stent placement procedure performed on (b)(6) 2019. The patient was admitted to the hospital on (b)(6) 2019. On (b)(6) 2019, a colonoscopy procedure was performed and found polypoid lesions with edema at 7cm from anal verge causing obstruction to passage of colonoscope. Abdominal x-ray was taken and showed midline surgical staples. On (b)(6) 2019, during colonoscopic stent placement, a guidewire was placed into the descending colon and two overlapping wallflex colonic stent size 12cm and 9cm were placed into the sigmoid colon and rectum. Reportedly, the patient was managed with i/v fluids, i/v antibiotics, i/v proton pump inhibitors (ppi) and supportive measures. An x-ray was performed post stent placement and showed both stents in situ. The patient was discharged on (b)(6) 2019. On (b)(6) 2019, the patient was admitted with complaints of fecal discharges from vagina, a recto-vaginal fistula, with pain in abdomen associated with vomiting for 1 day. Vital signs were taken with the following results: pulse rate of 80/min, respiratory rate of 20/min and blood pressure of 100/60 mmhg. Gastroenterology consultation was taken for pain in abdomen. Gynecology consultation was taken and advise for diversion colostomy. On (b)(6) 2019, the patient was discharged in stable condition with further follow up advice. On (b)(6) 2019, the patient underwent adhesiolysis and diversion ileostomy. On (b)(6) 2019, non-contrast volume scanning through kidneys, ureters and bladder (ncct kub) was performed. Review of the scan noted bilateral ileostomies seen in lower abdomen. A subcentimeter sized open defect was seen in the anterior abdominal wall in infra-umbilical region with an air channel continuous intra-abdominally. Tubular hyperdense stents are seen in rectum and sigmoid colon. There is evidence of air channel continuous with the intra-abdominal free air. Also a suspicious hypodense fluid is seen in pelvis anterior to rectal stent and at the left lateral aspect of sigmoid colon stent measuring 4. 2 x 2. 7 cm. On (b)(6) 2019, a pet ct scan was performed due to pain at ileostomy site with mucous discharge with vomiting and bleeding per vaginum for past 2-3 days. Reportedly, pet scan was being done for subsequent treatment planning. According to the complainant, the patient has not improved following stent placement but has become weaker. The complainant alleges that the stents are causing infection, bleeding and sepsis and plans to remove the stents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00054 |
| MDR Report Key | 9601839 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-09-08 |
| Date Mfgr Received | 2019-12-23 |
| Date Added to Maude | 2020-01-17 |
| 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 COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM |
| Generic Name | STENT, COLONIC, METALIC, EXPANDABLE |
| Product Code | MQR |
| Date Received | 2020-01-17 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-17 |