MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	B2080-040
Medical Device Problem Codes	Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the information provided, a definitive cause for the reported complaints could not be determined.It was reported by the account that the armada 35 balloon was successfully used for post dilatation per standard procedure.But during advancement, the balloon touched the edge of the implanted stent and pushed the implanted stent shortening/crushing the absolute pro vascular stent.In this case, it is possible that the absolute pro was stent was not full apposed such that the armada interacted with the edge of the stent resulting in the reported difficulty advancing the device and subsequently resulted in damage to the absolute pro; however, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional device referenced in b5 and d10 is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left common femoral artery.A.018 guidewire was advanced and the 9.0x30mm absolute pro vascular self-expanding stent system (sess) was deployed.The.018 guidewire was exchanged for a.035 guidewire to get more support and an 8.0x40mm armada 35 balloon was successfully used for post dilatation per standard procedure.But during advancement, the balloon touched the edge of the implanted stent and pushed the implanted stent shortening/crushing the absolute pro vascular stent.Another 8.0x40mm absolute pro vascular stent was implanted to extend the length of the previously implanted absolute pro vascular stent.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA¿
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22523127
• Report Number: 2024168-2025-07311
• Device Sequence Number: 8550810
• Product Code: LIT
• UDI-Device Identifier: 08717648155437
• UDI-Public: (01)08717648155437(17)270930(10)40402G1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: B2080-040
• Device Catalogue Number: B2080-040
• Device Lot Number: 40402G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 GUIDEWIRE; ABS PRO VASCULAR/9.0/30MM/135CM
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White