MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number S-55-150-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer did not report the device was returning.Investigation is not yet complete.A follow-up will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the mid to distal superficial femoral artery (sfa).A previously implanted stent was at the mid to proximal portion of the lesion.Pre-dilatation was performed and the supera stent delivery system was advanced through the previously implanted stent and deployed, so that it overlapped the other stent.It was thought that the stent was fully deployed; however, the physician did not retract the thumbslide fully.The physician then fully retracted the thumbslide and locked both levers.The stent delivery system was removed, but resistance was felt at a bend in the common iliac artery; however, the physician continued removal.It was then noted that the tip of the delivery system had separated and was seen at the location where resistance was noted.The stent was noted to have migrated and was partially in the sheath.The decision was made to remove the supera stent and the separated tip.A non-abbott dilatation catheter balloon was inflated in the supera stent, expanding the stent to fit the lumen of the sheath, and all devices were removed, including the separated tip.The physician then completed the procedure with balloon angioplasty, using a drug eluting balloon.No additional information was provided.

Manufacturer Narrative

G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.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 similar incidents.It should be noted that the supera instruction for use (ifu), states: following confirmed implantation of the supera stent, retract the thumbslide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.The tip separation likely occurred as the partially deployed stent was being withdrawn into the introducer sheath causing the tip to separate due to the reduced clearance.Based on the information provided, a conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA PERIPHERAL 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: 9215271
• MDR Text Key: 163134523
• Report Number: 2024168-2019-12776
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 8073061
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO DESTINATION 45CM 6FRENCH GUIDING CATHETER
• Patient Outcome(s): Required Intervention