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

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.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: PERIPHERAL 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 Key: 9140371
• MDR Text Key: 162629576
• Report Number: 2024168-2019-12247
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• 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 Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 1013465-100
• 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 Received: 10/11/2019
• 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