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

Catalog Number 42065200-120

Device Problems Material Separation (1562); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified lesion in the femoral artery.A 6.5x200mm supera self-expanding stent system (sess) was advanced to the lesion and the stent was deployed however it could not be detached from the sess.The sess with the deployed stent was removed as a single unit and a non-abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay was reported.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The inner member and the jacket, including the tip, were separated and not returned.The reported deployment difficulties were unable to be confirmed due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported difficulties.Additionally, the tip separation may the result of retracting the delivery system and partially deployed stent back into the introducer sheath causing the tip to detach.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed medwatch report, additional information was received.The returned device analysis noted the inner member and the jacket, including the tip, were separated and not returned.Follow up confirmed no portion of the device was left in the patient anatomy.No additional information was provided.

• 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: 10856313
• MDR Text Key: 217360391
• Report Number: 2024168-2020-09631
• 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: 02/26/2021

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: 07/31/2021
• Device Catalogue Number: 42065200-120
• Device Lot Number: 9080861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH:35 CM, 6 FR.