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

Catalog Number UNK SUPERA

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part and lot numbers were not provided.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 other supera stent referenced is filed under a separate medwatch report.

Event Description

It was reported that on (b)(6) 2021 a supera stent was implanted in the superficial femoral artery (sfa).On (b)(6) 2021, the procedure was performed to treat a heavily calcified lesion in the left popliteal artery.The vessel diameter was 6mm.A 6mm angioplasty balloon was used to prep the vessel.The 6.0x120mmx120cm supera self-expanding stent system (sess) (lot# 9061961) was advanced to the target lesion and deployed.Resistance was noted during removal of the sess.Troubleshooting was performed; the introducer sheath had to be pulled back and the stent deployed but was elongated and stretched to the previously implanted supera stent, which was difficult to visualize.The tip of the supera detached in the sfa but remained on the guide wire.A balloon was used to aid in removal of the tip from the anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information provided, a definitive cause for the reported difficulties could not be determined.It may be possible that anatomical conditions contributed to the difficulty; 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
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11387973
• MDR Text Key: 240316924
• Report Number: 2024168-2021-01517
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 014" X 315CM BAREWIRE; DESTINATION SHEATH
• Patient Age: 81 YR