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 2018-09-25 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48026 EVO-22-27-9-D manufactured by Cook Ireland Ltd.
[122166939]
The 510 (k) number: k163468. (b)(4). Device evaluation: the evo-22-27-9-d device of lot number c1385740 was implanted in the patient and is therefore unavailable for evaluation. With the information provided a document based investigation was carried out. Patient pre-existing conditions: pancreas cancer. Additional information received: was resistance encountered when advancing the wire guide through the stricture? - no. Was resistance encountered when advancing the introducer and stent into position? - no. Was dilation of the stricture completed prior to stent placement? - no. What was the diameter of the stricture? (mm) - unknown. What was the length of the stricture? (cm) - 4cm. (esophageal only) was the stent placed at the gastroesophageal junction? - n/a. Was the endoscope advanced into the stent after placement? - no. Did the patient undergo chemotherapy or radiation treatments after stent placement? - unknown. Images were not provided to support the complaint investigation. Therefore they could not be reviewed through cook research inc. (cri) root cause: a definitive root cause for the customer complaint could not be determined due to the limited information available and no images available for review. However, a possible root cause could be attributed to, as stated in the description of event? It was confirmed that the patient had been undergoing chemotherapy after stent placement?. As per? After stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding?. Document review: prior to distribution all evo-22-27-9-d devices are subjected to a visual inspection and functional checks to ensure device integrity. These inspections and functional checks are outlined in internal procedures in place at (b)(4). A review of the qc records for lot number c1385740 did not reveal any issues which could have contributed to this complaint issue. Manufacturing wok instructions include the following inspections;? Inspect for visual defects; i. E. Loose or embedded foreign materials, rough or sharp edges, kinks.? ? Ensure that there are no sharp edges or damage to the sheath tip area. "? Deploy the stent approximately 50%.? Upon review of complaints, this failure mode has not occurred previously with the lot number c1385740. Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1385740. Ifu review: as per ifu,? After stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding?. As stated in the description of event? It was confirmed that the patient had been undergoing chemotherapy after stent placement?. This therefore may have led to the stent becoming fractured. On review of the information provided, there is evidence to suggest that the user did not follow the instructions for use. Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony. From the information provided, there have been no adverse effects to the patient as a result of this occurrence. Complaints of this nature will continue to be monitored for potential emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[122166940]
Around (b)(6) 2018: the stent was placed in the curved site of the duodenum. On (b)(6) 2018: when olympus's jf-260v endoscope was inserted into the patient to treat cholangitis, the physician found that the stent wires forming "crowns" or near the "crown" at the stomach side was appeared to be broken and the stent edge was deformed. Since the endoscope could not be advanced through the stent due to the deformation of the stent edge, the physician had to leave the cholangitis untreated. The damaged stent remained inside the patient with no additional treatment as well. There have been no adverse effects to the patient reported. Updated with additional information (29/aug/2018, (b)(4)): it was confirmed that the patient had been undergoing chemotherapy after stent placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2018-00444 |
| MDR Report Key | 7906175 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-25 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-08-24 |
| Date Facility Aware | 2018-09-24 |
| Date Mfgr Received | 2018-08-28 |
| Device Manufacturer Date | 2017-08-03 |
| Date Added to Maude | 2018-09-25 |
| 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 | MS. HEATHER RYAN |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Phone | 061334440 |
| 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? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED |
| Generic Name | MUM STENT, METALIC EXPANDABLE, DUODENAL |
| Product Code | MUM |
| Date Received | 2018-09-25 |
| Model Number | G48026 |
| Catalog Number | EVO-22-27-9-D |
| Lot Number | C1385740 |
| Device Expiration Date | 2019-08-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 386 DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-25 |