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

Catalog Number 42065040-120

Device Problem Difficult to Advance (2920)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in 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.The additional xience xpedition device referenced is filed under separate medwatch report number.

Event Description

It was reported that the 6.5x40 supera self expanding system (sess) was deployed first in the superficial femoral artery (sfa), which occluded the profunda femoris artery.A 3.5x48mm xience xpedition stent delivery system (sds) was attempted to be advanced through the supera stent to open the profunda; however, the sds kept getting caught on the supera stent struts.The sds was removed and the procedure was completed with a non-abbott device.There were no adverse patient effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was not returned 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 similar incidents from this lot.The reported patient effect of occlusion is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.The investigation determined the reported difficult to advance appears to be related to circumstances of the procedure as it is likely that as the 3.5x48mm xience xpedition stent delivery system was attempted to be advanced through the supera stent interaction of devices resulted in the reported difficult to advance.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12515551
• MDR Text Key: 272903117
• Report Number: 2024168-2021-08458
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 42065040-120
• Device Lot Number: 0020461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.5X48MM XIENCE XPEDITION
• Patient Outcome(s): Required Intervention