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 2019-12-12 for EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED G48038 EVO-25-30-10-C manufactured by Cook Ireland Ltd.
[186814932]
K163468 - us clearance number. Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10
[186814933]
Complaint called in by dm on 15nov2019--did 15nov2019. As reported to customer relations: "stent would not deploy off the catheter. Unknown what the problem, dm and customer tried all troubleshooting they could think of and were not successful. (dm was not present, troubleshooting took place over the phone). Pulled it out and aborted. Will be reattempting today with the dm present. " a competitive device was utilized the next day with x-ray and representative (myself and competitor) there to support the staff and physician. Additional information received 10-dec-2019: the patient received a cat scan that evening (of the initial surgery) that showed that the stent was actually misdeployed proximal to the stricture. The stent was actually left in the patient and the physician did not use fluoroscopy during initial stent placement. Fda mdr reporting required: this event meets the criteria of an fda? Serious injury? Report as per fda guidelines? Medical device reporting for manufacturers (2016)? Section 2. 13 and 2. 15. Due to requirement ct scan and requirement for additional procedure next day to place competitor stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00712 |
| MDR Report Key | 9456796 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-12 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-11-14 |
| Date Facility Aware | 2019-11-14 |
| Date Mfgr Received | 2019-11-15 |
| Device Manufacturer Date | 2019-04-25 |
| Date Added to Maude | 2019-12-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. HEATHER RYAN |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer G1 | COOK IRELAND LTD |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED |
| Generic Name | MQR STENT, COLONIC METALLIC EXPANDABLE |
| Product Code | MQR |
| Date Received | 2019-12-12 |
| Returned To Mfg | 2020-01-07 |
| Model Number | G48038 |
| Catalog Number | EVO-25-30-10-C |
| Lot Number | C1607646 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 203 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | O HALLORAN ROAD LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-12 |