MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number CQF7588

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

Patient Problem Occlusion (1984)

Event Date 04/25/2019

Event Type  malfunction  

Event Description

After ballooning, the surgeon was removing the balloon catheter and a fiber caught the end of stent and moved it.The surgeon was able to put stent back into place.Notes from operative report:.25 cm 4 french sheath was inserted in hobbs just proximal to the area of pre-existing stent.Using a berenstein catheter support and stiff glidewire, the area of the previously stented portion was able to be crossed and the wire placed past the ventricle into portion of ivc (inferior vena cava).As now the plan was to treat this area with stent graft placement as well as angioplasty, the sheath was upsized to 7 french by 25 cm sheath.The area was predilated using 6 mm x 100 mm angioplasty balloon (conquest, bard).This then allowed for a larger balloon angioplasty using 8 mm x 80 mm angioplasty (conquest, bard).Subsequent to this, an attempt was made to pass the fluency stent graft.However, the distal portion of the pre-existing stents had one of the struts that was preventing the passage of the stent graft.Therefore, stronger support was obtained by switching to supercore wire.During this process, venogram was performed at the level of the vena cava and multiple points, and it was noted that the vena cava appeared to be occluded with flow through the gonadal veins.Next, 8 x 60 mm mustang balloon was utilized (boston scientific) to angioplasty and open up the area of the stent struts.Subsequent to this, the fluency stent graft was able to be passed bareback.9 x 100 mm fluency covered stent was then deployed from the innominate vein (patient has known right ij [internal jugular] occlusion) into the axillary vein and into now patent portion of the brachial vein.This was post angioplastied with initially the 8 x 80 mm conquest balloon with some infolding noted, therefore repeated with 8 x 60 mm mustang.Postprocedural venogram/fistulogram showed robust and brisk flow through the av graft into the brachial vein into the stent graft and into the right atrium without any hindrance of flow.There was no longer evidence of significant collateral flow as was noted prior to the venous outflow treatment.Clinically, the patient felt immediate relief of pressure within his right upper extremity.There was a palpable thrill within the graft.Patient was taken to recovery room in stable condition.

• Brand Name: CONQUEST 40
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st; tempe AZ 85281
• MDR Report Key: 8607363
• MDR Text Key: 144956995
• Report Number: 8607363
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CQF7588
• Device Catalogue Number: CQF7588
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Weight: 106