MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number A2025-200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia (1942)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4); a partial udi is being reported because the lot number was not provided.(b)(6).On (b)(6) 2016, the patient underwent surgical thrombectomy of the left femoral to distal bypass with excellent results; arteriograms taken during this surgery showed very diseased anterior tibial artery that would unlikely be able to support long term graft patency without improved flow.Concomitant medical products: guide wire: 0.014 balance middleweight, sheath: 6fr 11cm.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effect of ischemia is listed in the armada 14 instructions for use.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The additional non-surgical treatment was related to operational context.

Event Description

It was reported that on (b)(6) 2016, the patient presented with a perforation at the distal anastamosis of the 80 to 90% severely stenosed left femoral tibialis bypass graft.With an unspecified 6fr 11cm sheath in place, a 0.014 balance middleweight guide wire was advanced through the graft to the anterior tibialis artery.A 2.5mm x 200mm x 150cm armada 14 balloon dilatation catheter was advanced and angioplasty was performed via inflation for 10 minutes.The balloon was withdrawn and an angiography showed persistence of perforation and worsening distal flow for an unknown reason.Balloon angioplasty was performed again for 3 minutes then the balloon was withdrawn; angiography showed improved distal flow.A 2.8x26 rx graftmaster covered stent was then placed at the distal end of the perforation.As the perforation was discovered to be larger than initially visualized, a 4.0x26 rx graftmaster was deployed, proximally overlapping the 2.8x26 rx graftmaster.Both graftmaster covered stents sealed the perforation.The proximal stent was post-dilated as standard procedure using a 4.5x15 nc trek balloon inflated to high pressure.An angiography confirmed closure of the perforation and a timi flow of 3 at the anterior tibialis.Reportedly, the graftmaster devices did not cause or contribute to any complications or adverse events.No additional information was provided.

• Brand Name: ARMADA 14 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5701193
• MDR Text Key: 46619948
• Report Number: 2024168-2016-03625
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A2025-200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 108