MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B1100-040
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The investigation determined the reported balloon rupture and balloon separation appear to be related to operational circumstances of the procedure.In this case, based on the reported information, it is likely that during inflation, the balloon became compromised and/or damaged against the heavily calcified anatomy and/or previously implanted stent resulting in the reported balloon rupture at 8 atmospheres.The balloon likely did not refold properly and further manipulation during retraction, likely resulted in the balloon separation in the previously implanted stent and anatomy.Additionally, the treatment appears to be related to the operational context of the procedure as an unsuccessful attempt was made to snare the separated tip.Two ominilink stents were then advanced, kissing stent technique, into the distal aorta, to embed the tip of the balloon into the lesion.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, 70% re-stenosed stent in the internal iliac artery.The armada 35 was prepared per the ifu and advanced to the lesion, without issue, via left groin access with an 8f sheath.The balloon ruptured on its 1st inflation at 8 atmospheres (atm) and the device was removed, without issue; however, it was noted that the distal tip of the balloon had separated completely and was trapped up against the previous implanted stent and severe calcium.An attempt was made to snare the separated tip, but it was unsuccessful.Two omini link stents were then advanced , kissing stent technique, into the distal aorta, to embed the tip of the balloon into the lesion.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11383148
• Report Number: 2024168-2021-01506
• Device Sequence Number: 4568323
• Product Code: LIT
• UDI-Device Identifier: 08717648154942
• UDI-Public: 08717648154942
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: B1100-040
• Device Catalogue Number: B1100-040
• Device Lot Number: 00602G2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/25/2021
• 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: 67 YR
• Patient Weight: 64