MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for UNKNOWN N/A manufactured by Cook Inc.
[141033952]
Common name: unknown. Rpn and lot information were not provided in the source article. Product code: unknown. Rpn and lot information were not provided in the source article. Pma/510(k) #: unknown. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[141033953]
As reported to customer relations: "a (b)(6) male presented with a 2-year history of canadian class 3 angina, refractory to medical therapy. He had a background history of an ischemic cardiomyopathy, having sustained two previous myocardial infarctions and had undergone surgical revascularization twice previously (last operation 21 years prior). He had a primary prevention implantable cardioverter defibrillator in situ. His comorbidities included paroxysmal atrial fibrillation, hypertension, and dyslipidemia. Renal function was preserved. Echocardiography revealed moderate left ventricle (lv) systolic dysfunction with an akinetic apex and hypokinetic inferior wall. A nuclear scan confirmed viability in the inferior wall. Coronary angiography demonstrated occluded proximal native vessels with occluded vein grafts to the left circumflex (lcx) and right coronary arteries with a patent left internal mammary to left anterior descending artery. Pci to the lcx cto then pci to the right coronary artery (rca) cto was planned. Pci to the lcx cto was successful using an antegrade dissection re-entry strategy (crossboss catheter and stingray wire/balloon for controlled re-entry, st jude medical, st paul, mn) and an excellent angiographic result was achieved after implantation of three overlapping drug eluting stents (fig. 1; supporting information videos 1 and 2). Pci to the rca was undertaken in the same sitting as a primary retrograde strategy via epicardial collaterals from the lcx (fig. 2). The collaterals were crossed with a sion wire (asahi intec, aichi, japan) supported by a corsair catheter (asahi intec, aichi, japan). The procedure was completed by retrograde dissection reentry, wire externalization and deployment of five overlapping drug eluting stents. A small perforation in the small, tortuous epicardial collateral was evident on withdrawal of the retrograde equipment (fig. 3; supporting information videos 3 and 4). As the perforation appeared small and contained, no immediate intervention was performed. Thirty minutes after the completion of the procedure, the patient became hypotensive requiring inotropic support. Urgent echocardiography revealed a small, retrocardiac collection that was causing left atrial compression and compromising ventricular filling (fig. 4), while urgent computed tomography scan (ct) showed a large retrocardiac, intrapericardial hematoma causing significant left atrial compression (supporting information videos 5 and 6). Urgent ct guided percutaneous drainage of the hematoma was performed by the interventional radiology team. Using a right lateral thoracic approach, a 20-gauge needle (20-cm long) was advanced through the right lung into the intrapericardial hematoma. An 0. 018-in. Diameter nitinol guide wire was advanced through the needle, over which a 5 french coaxial introducer (merit medical, south jordan, ut) was delivered into the hematoma. A rosen wire (cook medical, bloomington, in) was introduced through this that afforded delivery of a 12 french pigtail drainage catheter (cook medical). The hematoma was evacuated and the blood pressure immediately improved. (figs. 5 and 6). The procedure was complicated by a right hemothorax, which required percutaneous drainage. An excellent recovery was made and the patient discharged 5 days later. He remained well and free of angina at 6-month follow up. This report # was created to detail the involvement of the unknown cook 12 french pigtail drainage catheter mentioned in the source article. Mdr #1820334-2019-00788 was created to detail the involvement of the cook rosen wire mentioned in the source article.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00789 |
| MDR Report Key | 8482466 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-05-29 |
| Date Mfgr Received | 2019-05-09 |
| Date Added to Maude | 2019-04-04 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN |
| Product Code | EYB |
| Date Received | 2019-04-04 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-04 |