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

Catalog Number 42045080-120

Device Problems Difficult or Delayed Activation (2577); Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

The stent remains in the patient.The delivery system 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 performed to treat a moderately tortuous and moderately calcified lesion in the popliteal artery.Following pre-dilatation with a 4.0x60mm armada 35 balloon catheter, a 4.5x80mm supera self-expanding stent system (sess) was advanced through a 7f sheath.During deployment it was noted that the stent was compressing.An attempt to deploy the stent at nominal was made; however, failed and the entire target lesion could not be covered.The sess was removed under fluoroscopy.Another 4.5x80mm supera stent was used to successfully cover the remainder of the target lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported deployment difficulty and stent shortening were not confirmed as the stent was already fully deployed and not returned.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 other similar complaints.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that forward/pushing movement of the supera delivery system during stent deployment caused the stent to shorten/compress; 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: 11186736
• MDR Text Key: 230276803
• Report Number: 2024168-2021-00530
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 42045080-120
• Device Lot Number: 9100961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: COMMAND ES; SHEATH: 7F