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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013465-100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vasoconstriction (2126)
Event Date 08/27/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number (b)(4). The device was discarded and will not return for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that on (b)(6) 2019, the patient presented with ischemic rest pain of the right foot. Per imaging, a complex chronic total occlusion of the right superficial femoral artery (sfa) and proximal right popliteal artery. The calcification was severe and eccentric. Sfa and popliteal balloon angioplasty was performed using an armada18 (3. 0mmx100mmx150cm-otw), and non-abbott balloon catheters. Following, there was significant recoil due to the severe calcification. As treatment, additional balloon dilatation was performed and the recoil remained. A 3. 5x38mm promus stent was subsequently implanted. Post stent implantation, an arterial-venous (av) fistula was noted between the anterior tibial (at) artery and at vein. As treatment for the av fistula, balloon angioplasty was performed without resolve. A 3. 5x16mm graftmaster (gm) stent was implanted in the distal, stented portion. Reportedly, the gm stent sealed at the implantation site and performed as intended. There was a significant reduction in the av fistula and prolonged balloon inflation was performed in the proximal portion. Repeat imaging was performed displaying a patent right sfa and popliteal artery going into the at with the previously reported recoil. The procedure was completed and the patient was in stable condition. Per physician, the gm stent did not cause or contribute to complications or adverse events. No additional information was provided regarding this issue.
 
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Brand NameARMADA 18 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9140371
MDR Text Key162629576
Report Number2024168-2019-12247
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1013465-100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/01/2019 Patient Sequence Number: 1
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