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

Catalog Number 42055200-120

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The stent remains in the patient.The device will not be returned for evaluation.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 on 10/08/2020 was to treat the 100% stenosed left proximal superficial femoral artery (sfa).As an introducer sheath was not used, slight resistance was felt during deployment of the 5.5x200 supera self-expanding stent (ses) and the stent moved a little bit forward with the proximal part of the stent ending in the common femoral artery.A control injection confirmed a good flow.On (b)(6) 2020 the patient experienced a hemorrhagic stroke, confirmed with cerebral ct scan.The supera stent was confirmed to be patent.Medication was administered and the patient remained hospitalized.The patient was discharged on (b)(6) 2020.Per the physician, the stroke was not related to the supera stent.No additional information was provided.

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 revealed no other similar complaints.It should be noted that the supera instruction for use (ifu) states: using standard technique, gain access at an appropriate anatomical site utilizing an appropriately sized introducer sheath.In this case, it could not be determined if using the supera without the use of an introducer sheath caused or contributed to the difficulties.Based on the information provided, a definitive cause for the difficulties could not be determined.It may be possible that delivering and deploying the supera stent without the use of an introducer sheath contributed to the slight resistance noted during deployment and causing the stent to slightly move forward during deployment; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: SUPERA 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: 10801913
• MDR Text Key: 215607582
• Report Number: 2024168-2020-09300
• 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: 11/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 42055200-120
• Device Lot Number: 9042961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1