MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER

Catalog Number UNKNOWN TRUE

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the investigation is inconclusive for the reported rupture, as the devices were not returned for evaluation.Per the information in the reported journal article, the devices were used for in-vitro bench testing on aortic tissue valves, in an attempt to fracture the valves.The devices were likely inflated past the rated burst pressure.Therefore, the root cause is likely user-related.However, the definitive root cause for the reported ruptures could not be determined based upon the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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.

Event Description

It was reported in an article in the annals of thoracic surgery titled 'bioprosthetic valve fracture to facilitate transcatheter valve-in-valve implantation', that during in-vitro bench testing on aortic tissue valves, three high pressure balloons allegedly ruptured prior to the valves fracturing.There was no patient contact.

• Brand Name: TRUE DILATATION CATHETER
• Type of Device: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8122824
• MDR Text Key: 129054607
• Report Number: 2020394-2018-02143
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN TRUE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 12/01/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1