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 2020-03-06 for SPIDER FX manufactured by Covidien.
[188186154]
Journal article: one-day, sequential carotid artery stenting followed by cardiac surgery in patients with severe carotid and cardiac disease journal: vascular medicine year: 2019 ref: doi: 10. 1177/1358863x19872547. Age: average age. Sex: majority gender. Date of event: date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events. Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product. Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188186155]
The aim of this study is to evaluate the safety and feasibility of the one-day, sequential approach by carotid artery stenting (cas) immediately followed by cardiac surgery. The study included 70 consecutive patients with ica stenosis coexisting with severe coronary/valve disease, who underwent one-day, sequential cas and cardiac surgery. All cas procedures were performed according to the? Tailored? Algorithm with a substantial use of proximal neuroprotection devices and stents were implanted in most cases. The majority of patients underwent isolated coronary artery bypass grafting or isolated valve replacement. No major adverse cardiac and cerebrovascular events (macce) occurred at the cas stage. There were three perioperative macce: one myocardial infarction and two deaths. All macce were related to cardiac surgery and were due to the high surgical risk profile of the patients. There were 19 non-macce complications. Three non-macce complications were related to cas and were associated with femoral artery puncture: two pseudoaneurysms, managed by local compression/ percutaneous thrombin injection, and one acute right limb ischaemia on the second postoperative day, treated with embolectomy. A further 16 non-macce complications were associated with cardiac surgery. Up to 30 days, no further macce were observed. No perioperative or 30-day neurological complications occurred. In this patient series, one-day, sequential cas and cardiac surgery was relatively safe and did not result in neurological complications. Thus, a strategy of preoperative cas could be considered for patients with severe or symptomatic ica stenosis who require urgent cardiac surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2020-00068 |
| MDR Report Key | 9797185 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-09-23 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-06 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 4600 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIDER FX |
| Generic Name | CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE |
| Product Code | NTE |
| Date Received | 2020-03-06 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 4600 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |