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

Model Number	B2060-120
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017- excessive force.
Event or Problem Description
It was reported that the procedure was to treat the right external iliac artery with heavy calcification.A 6x80 mm supera self expanding stent (ses) was deployed with no issues and a non-abbott ses was used to extend the supera stent.While deploying the non-abbott ses, the stent began to flower and the wheel was continued to be turned.The physician then began to pull the stent back along with the 7fr sheath, and the system became stuck in the calcium of the right iliac artery.The stent began flower more when attempting to pull back.Approximately three or more balloons were used in an attempt to pull the stent out - numerous non-abbott balloons and the 6x120 mm armada percutaneous transluminal angioplasty (pta) catheter.The armada was advanced through the non-abbott ses and there was resistance noted.The balloon was inflated and deflated in an attempt to grab the stent, but the armada pta catheter sheared off in the patient after there was resistance with the non-abbott ses during removal and force was applied.A snare was used to retrieve the armada balloon.The snare was then used in an attempt to snare and retrieve the stent and system.During the last attempt to retrieve the stent with the snare, the right iliac artery became perforated and the patient was bleeding out and coding.A non-abbott covered stent was used to treat the perforation and two hours after the start of the procedure the patient was stable.However, the patient began to bleed later that night and they expired early the next morning.In the physician's opinion, the supera stent and armada balloon did not cause or contribute to any adverse patient effects or death.No additional information was provided.
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 received, the investigation determined that the reported difficulty advancing and removing the device from the stent and unexpected medical intervention appear to be related to operational context; however, the reported separation appears to be related to user error/operational context.It was reported by the account that upon removal of the dilatation catheter, resistance was noted, and force was applied.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use (ifu) states: maintaining a vacuum in the balloon, withdraw the catheter.Note: gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as one unit.In this case, the physician did not follow the instructions for use.Instead of using gentle counterclockwise twisting motion to remove the device, force was applied which likely contributed to the reported separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9: corrected device available for evaluation from yes to no.

• 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: 22145282
• Report Number: 2024168-2025-05744
• Device Sequence Number: 17977632
• Product Code: LIT
• UDI-Device Identifier: 08717648155307
• UDI-Public: (01)08717648155307(17)271231(10)40718G1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/27/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: B2060-120
• Device Catalogue Number: B2060-120
• Device Lot Number: 40718G1
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 99 KG