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

Catalog Number 42055150-080

Device Problems Stretched (1601); Activation Failure (3270)

Patient Problems Ischemia (1942); Thrombosis (2100); Prolapse (2475)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2020, a percutaneous intervention was performed on the right superficial femoral artery (sfa), moderately calcified lesion.Pre-dilatation was performed using a 6mm balloon catheter.Following, a supera stent delivery system (sds) advanced to the without issues.The stent was partially deployed at the intended area.When the physician unlocked the deployment lock to fully release the stent from the device, the stent would not release.Another sheath advanced to remove the device and the supera stent stretched, while remaining attached to the delivery system.Nothing detached.The device was removed from the anatomy without further device issues.Reportedly, there was a clinically significant delay as this delay worsened the patients critical limb ischemia.The patient was transferred to critical care for thrombolysis and additional heparin was provided.Per physician, there was most likely thrombus and plaque, located in the subintimal tract, adherent to the supera stent, which was then released in the act of re-sheathing.Per physician, the event most likely required prolonged hospitalization.No additional information was provided regarding this issue.

Manufacturer Narrative

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 indication of a lot specific product issue.It should be noted that the reported patient effects of ischemia, thrombosis, and claudication are listed in the supera instructions for use as known potential patient effects associated with peripheral percutaneous intervention.Based on the information provided, the reported difficulties appear to be related to case circumstances.It is likely that the introducer sheath was located too closed to the stent during deployment causing the stent to partially deploy into the sheath.The stent elongation likely occurred as the introducer sheath was being removed.The tip detachment likely occurred when the tip was pulled into the reduced clearance of the stent partially deployed in the sheath.The surgical procedure was related to circumstances of the procedure.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: 9728415
• MDR Text Key: 181540160
• Report Number: 2024168-2020-01615
• Device Sequence Number: 1
• Product Code: NIP
• 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: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 42055150-080
• Device Lot Number: 9072361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention