MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-12-01 for TRUE DILATATION CATHETER UNKNOWN TRUE manufactured by Bard Peripheral Vascular, Inc..
[129054607]
No device, no medical records, or no medical images were provided to the manufacturer. The lot number for the device was not provided; therefore, a review of the device history records could not be performed. The investigation of the reported event is currently underway. Journal article review: based on review of this article on 02/8/18: in vitro bench testing on aortic tissue valves was performed on 19mm and 21mm mitroflow (sorin, milan, italy) magna and magna ease (edwards, life-sciences, irvine, ca) trifecta and biocor epic ( st. Jude medical, minneapolis, mn) and hancock ii and mosaic (medtronic, minneapolis, mn). High pressure balloons tru dilation, atlas gold, and dorado (c. R. Bard, murray hill, nj) were used to determine which valves could be fractured and at what pressure fracture occurred with a high pressure balloon to facilitate valve-in-valve transcatheter aortic valve replacement. These balloons were 1mm larger than the labeled surgical valve size. The mitroflow, magna, magna ease, biocor epic and mosaic valves were successfully fractured using both tru dilation and atlas gold balloons, whereas three trifecta and three hancock ii valves could not be fractured using any high pressure balloon inflation technique (balloon rupture occurred before fracture during all attempts); additional attempt was made using a? Kissing? Double balloon technique with two dorado balloons. Only the internal valve frame was fractured, and the sewing cuff was never disrupted. Manufacturer? S rated burst pressures for balloons were exceeded, with fracture pressures ranging from 8 to 24 atmospheres depending on the surgical valve. Testing further demonstrated that fracture facilitated the expansion of previously constrained, under expanded transcatheter valves (both balloon and self-expanding) to the manufacturer? S recommended size. Allen, k. B. , chhatriwalla, a. K. , cohen, d. J. , saxon, j. T. , aggarwal, s. , hart, a. ,. . . Borkon, a. M. (2017). Bioprosthetic valve fracture to facilitate transcatheter valve-in-valve implantation. The annals of thoracic surgery, 104(5), 1501-1508. Https://doi. Org/10. 1016/j. Athoracsur. 2017. 04. 007.
Patient Sequence No: 1, Text Type: N, H10
[129054608]
It was reported in an article in the annals of thoracic surgery titled 'bioprosthetic valve fracture to facilitate transcatheter valve-in-valve implantation', that in three cases high pressure balloons ruptured prior to valves fracturing in vitro. There was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-02143 |
| MDR Report Key | 8122824 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-12-01 |
| Date of Report | 2019-01-16 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2018-12-01 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUE DILATATION CATHETER |
| Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Product Code | OZT |
| Date Received | 2018-12-01 |
| Catalog Number | UNKNOWN TRUE |
| 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 | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-01 |