MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2030-120
Medical Device Problem Codes	Off-Label Use (1494); Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The supera stent is filed under a separate medwatch report number.
Event or Problem Description
It was reported the procedure was to treat the right superficial femoral artery (sfa) with short chronic total occlusion.A 6f sheath was used.The vessel was 6 mm and laser atherectomy was performed.A 6.0x120 mm supera self-expanding stent (ses) was advanced to the lesion without resistance and deployed.Fluoroscopy was used to confirm the stent had fully emerged/deployed when removing the delivery system.However, when a balloon was being advanced for post dilatation, the stent seemed blocked and it was observed that the supera tip had separated and was stuck at the proximal entry of the supera stent.The sheath that was already in the anatomy was advanced to capture the tip but also removed the implanted stent.No additional stent was implanted.Manual pressure was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.Return device analysis noted that the 6f sheath was returned with a 3.0 armada 14 balloon catheter inserted inside.It appears that the balloon had been inflated and was likely used to help remove the separated tip and subsequently the implanted stent.It was confirmed that there was no device issue with the armada balloon.Additional information was received: the sfa was pre-dilated with a 6.0 balloon prior to deployment of the supera ses.There was no reported resistance removing the supera stent system.Angiography showed good wall apposition and no post-dilatation was needed.The 3.0 armada balloon was advanced to possibly treat the tibial artery, but could not cross and it was observed via additional imaging that the tip of the supera ses had detached and was blocking the proximal end of the supera stent.The 3.0 armada balloon was then used to retrieve the tip of the supera ,and inadvertently removed the implanted stent.No additional treatment was performed, and no additional stent was implanted.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the complaint information and analysis of the returned unit.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.It should be noted that armada 14 instructions for use (ifu) states: the device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The 2.0 to 4.0 mm balloon diameters are also indicated for post-dilatation of stents.In this case the reported ifu violation did not cause or contribute to the reported failure to advance, but did contribute to the stent removal (damage).Based on the information provided, the balloon inability to advance was caused by the separated supera stent tip.The off-label use of the armada to remove the separated tip, and subsequently the supera stent was based on case circumstances.Additionally, the damages noted in the return goods analysis were also caused by the case circumstances.There is no indication to suggest a product quality issue with respect to manufacture, design, or manufacture, or labeling of the armada 14 device.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10670949
• Report Number: 2024168-2020-08533
• Device Sequence Number: 2728252
• Product Code: DQY
• UDI-Device Identifier: 08717648156106
• UDI-Public: 08717648156106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• 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): 11/03/2020

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 Expiration Date: 11/30/2023
• Device Model Number: A2030-120
• Device Catalogue Number: A2030-120
• Device Lot Number: 0060941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6.0X120 MM SUPERA SELF-EXPANDING STENT.; 6FR TERUMO SHEATH.
• Patient Age: 74 YR