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 COLONIC M00565060 6506 manufactured by Boston Scientific Corporation.
[134928922]
(b)(6). (b)(4). According to the complainant, the suspect device was disposed 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
[134928923]
Note: this report pertains to one of the two devices used during the same procedure. Refer to manufacturer report # 3005099803-2019-00353 and 3005099803-2019-00380 for the associated device. It was reported to boston scientific corporation on january 10, 2019 that two wallflex colonic stents were implanted to treat a 6cm stenosis in the sigmoid and descending colon during a stent placement procedure performed on (b)(6) 2018. According to the complainant, the first 12cm wallflex colonic stent (the subject of this report) was advanced through the endoscope and was deployed; however, the stent "jumped" and was placed not on the stenosis. A second 9cm wallflex colonic stent (the subject of mfr. Report # 3005099803-2019-00380) was implanted in a stent-in-stent placement. Reportedly, on (b)(6) 2018, post stent placement procedure, the patient experienced an abdominal pain. A computed tomography (ct) scan was performed and confirmed intestinal perforation. Reportedly, the perforation site was on the descending colon where the distal end of the 9cm wallflex colonic stent was in placed; however, the relationship between the stent and perforation was unknown. Antibiotic were administered to the patient. On (b)(6) 2018, the patient had expired. Per the physician, peritonitis was the cause of patient's death. Note: on (b)(6) 2019, boston scientific corporation received an additional information that the 9cm stent was a wallflex colonic stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00353 |
| MDR Report Key | 8302803 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-04 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2018-09-11 |
| 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 COLONIC |
| Generic Name | STENT, COLONIC, METALIC, EXPANDABLE |
| Product Code | MQR |
| Date Received | 2019-02-04 |
| Model Number | M00565060 |
| Catalog Number | 6506 |
| Lot Number | 0022635673 |
| 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 |