MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,other report with the FDA on 2019-05-10 for UNKNOWN manufactured by Cook Inc.
[144710186]
Common name, product code= dqx wire, guide, catheter; dqx. Concomitant products= edwards sapien xt valve and novaflex delivery system, medtronic corevalve, abbott 10f prostar xl, unknown balloon devices. Occupation = unknown. Pma/510(k) number = pre-amendment. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144710187]
The literature has reported trends in outcome and survival following transcatheter aortic valve implantation (tavi) procedures, during which the cook safe-t-j heavy duty fixed core wire guide was used, among other products. Between 2010 and 2013, 429 patients underwent tavi in the study center. All patients involved in the study had severe symptomatic aortic stenosis and the logistic euroscore was greater than or equal to 20% in case of fragility or co-morbidity, contraindicating surgical aortic valve replacement. The mean patient age was 84. 1 years. During the procedures, after crossing the aortic valve, a pre-shaped, 260 cm long, 0. 035 inch amplatz extra stiff wire (complaint device) was placed into the ventricle. Balloon sizing was performed in all cases under rapid ventricular pacing, as a final annulus assessment to choose the valve size. Valve positioning was based on fluoroscopy, using annular calcification as a landmark. Another manufacturer? S prosthesis was then delivered using rapid ventricular pacing. The femoral arteriotomy was closed using another manufacturer? S device. In the absence of a persistent atrioventricular block, the pacing lead was removed at the end of the procedure. Patients were monitored in the intensive care unit for at least 24 hours after valve implantation. There has been no alleged malfunction of the complaint device. Patient outcomes reported in the article are as follows. Two patients died from annulus rupture despite a bailout valve-in-valve procedure; this is reported under this mdr. One patient presented with a left ventricular perforation and died at day 1; this event is reported under mdr 1820334-2019-01190. There were nineteen other unspecified cases of 30-day patient deaths; this is reported under mdr 1820334-2019-01191. Five cases of annulus rupture not associated with death are reported under mdr 1820334-2019-01192. Eight cases of cardiac tamponade are reported under mdr 1820334-2019-01193. Three cases of urgent cardiac surgery are reported under mdr 1820334-2019-01194. Fourteen patients were reported to have experienced a stroke; this is reported under mdr 1820334-2019-01195. Sixty-nine cases involved bleeding that required a blood transfusion; this is reported under mdr 1820334-2019-01196. Fifty-four cases of acute kidney injury were reported; this is reported under mdr 1820334-2019-01197. There were eighty-five cases of vascular complications; this is reported under mdr 1820334-2019-01198. There were seven cases of periprocedural myocardial infarction; this is reported under mdr 1820334-2019-01199. Citation: avinee, g. , durand, e. , elhatimi, s. , bauer, f. , glinel, b. , dacher, j. N. , cellier, g. , viart, g. , tron, c. , godin, m. , litzler, p. Y. , criber, a. , eltchaninoff, h. (2016). Trends over the past 4 years in population characteristics, 30-day outcomes and 1-year survival in patients treated with transcatheter aortic valve implantation. Archives of cardiovascular disease, 109 (457-64). Retrieved from: http://dx. Doi. Org/10. 1016/j. Acvd. 2016. 01. 016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01189 |
| MDR Report Key | 8599898 |
| Report Source | FOREIGN,LITERATURE,OTHER |
| Date Received | 2019-05-10 |
| Date of Report | 2019-09-10 |
| Date Mfgr Received | 2019-09-09 |
| Date Added to Maude | 2019-05-10 |
| 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 | 3 |
| Brand Name | UNKNOWN |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2019-05-10 |
| 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. Death; 2. Other; 3. Required No Informationntervention | 2019-05-10 |