MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number 1012535-100

Device Problems Entrapment of Device (1212); Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the highly calcific left superficial femoral artery (sfa) to the tibial trunk.The right common femoral artery (cfa) was accessed with a 45 cm sheath to go up and over the aortic bifurcation which was noted to be very steep.Atherectomy was performed from the cfa to the tibial trunk on low/medium.The atherectomy device was removed and a command 18 guide wire was inserted.Angioplasty was performed with an unspecified balloon and then a 5.5x200 mm armada 18 was used from the distal sfa to the cfa.An armada 35 was then used to further dilate a resistant portion of the lesion.A 5.5x150 mm supera self expanding stent (ses) was then deployed with good outcome in the distal-mid sfa.The 7.0x100 mm absolute ses was then inserted and advanced with resistance noted with the bifurcation.The device was unlocked and after 6 clicks, the entire device locked down and would not move.The guide wire was then removed and replaced with a.035 non-abbott guide wire.The absolute ses was attempted to deploy again but still would not deploy.A supracore guide wire was then placed, and it was noted that the stiffer guide wire had no effect on the angles of the bifurcation.The absolute ses was pulled into the sheath to remove the device and during removal the stent caught on a calcium rock.The delivery system would not come out.The sheath was pushed and a kink was suspected.At this point the physician was pulling aggressively on the system to remove it and the whole aortic bifurcation was moving.All maneuvers to remove the device were attempted and finally the vascular surgeon was called in to do an endarterectomy.While waiting for the surgeon the supracore guide wire was swapped with a non-abbott guide wire.The surgeon dissected down to the lesion and grabbed the wire with hemostats to create a closed system so they can ¿floss¿.Dissection up to the cfa was performed and about 8 large rocks of calcium were removed.When the stent was reached, the tip of the stent up to the sheath was broken with hemostats.¿flossing¿ was continued and the surgeon was able to grab the sheath at the endarterectomy site and pull and the portion that was able to be removed was cut with wire cutters.Eventually the stent was able to be removed from the same site as well.The sheath still needed to be removed and while pulling on the sheath it was noted that the sheath was coming out but the hypotube was staying behind.With the use of more hemostats and the ¿flossing¿, the sheath and all remaining devices were able to be removed.The closed system was not broken until it was confirmed that all device and device portions had been removed.The patient had a lot of bleeding on the right side and experienced hypotension during the procedure.It was treated with 5 units of fresh frozen plasma.The incision on the right side was stitched outside of the artery.On the other side, a bovine patch was placed and the incision was sewn shut.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported deployment issue, deformation of the shaft, jammed thumbwheel, separations, and stent damage was confirmed.The reported difficulty to advance and entrapment in the vessel were unable to be confirmed/tested as it was based on case circumstances.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 indication of a lot specific product issue.The reported patient effects of hypotension and hemorrhage are listed in the absolute pro instruction for use as known adverse events associated with the use of a stent in peripheral arteries and / or biliary tree.The investigation determined that the reported difficulties were likely related to circumstances of the procedure.It is likely that anatomical conditions contributed to the reported difficulties.It is likely that the distal shaft was bent/entrapped over the very steep heavily calcified aortic bifurcation preventing movement of the shaft lumens and thumbwheel.Additionally, during the attempt to remove, the partially deployed stent was caught on the heavy calcification preventing removal.The additional patient effects, surgery and treatments were related to procedural circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Attachment: user medwatch #5093763na.

Event Description

Additional information provided via a user facility medwatch: stent did not deploy properly, physician was going to remove, he was unable to remove as the stent ruts and platform caught of plaque.Leg had a large amount of plaque.Vascular surgeon came and removed the stent from the illiac bifurcation.Cut down was done in order to retrieve the stent.Event outcome: hospitalization, required intervention.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9759657
• MDR Text Key: 183094164
• Report Number: 2024168-2020-01817
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176098
• UDI-Public: 08717648176098
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 7060161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/16/2020; 04/13/2020; 07/20/2020
• Supplement Dates FDA Received: 04/08/2020; 05/04/2020; 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5.5X150 SUPERA SES; GUIDE WIRE: COMMAND 18, SUPRACORE, .035 GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 82