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

Catalog Number	1013465-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 or Problem 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.
Additional Manufacturer Narrative
The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.In this case, there was no reported device malfunction associated with the armada 18 balloon catheter.The reported patient effect of vessel spasm or recoil is listed in the armada 18 instruction for use as a known potential adverse event associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9140371
• Report Number: 2024168-2019-12247
• Device Sequence Number: 19568541
• Product Code: LIT
• UDI-Device Identifier: 08717648207891
• UDI-Public: 08717648207891
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1013465-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 74