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

Catalog Number 42045040-120

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned as the stent remains in the patient.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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported deployment difficulty.It may be possible that the distal sheath of the supera delivery system was entrapped or restricted in the anatomy such that the ratchet efficiency was compromised; 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.

Event Description

It was reported that the procedure was performed to treat a moderately tortuous and mildly calcified lesion in the popliteal artery.A 6fx45cm sheath was advanced into the 4.5mm diameter vessel.The lesion was pre-dilated with a 3x80mm armada 18 balloon catheter (bc) for one minute at 8 atmospheres (atms) and a 4x100mm armada 18 bc for one minute at 8 atms.A 4.5x40mm supera self-expanding stent system (sess) was advanced.The deployment lock was rotated to the unlocked position and the thumb slide fully advanced to completely release the stent; however, under fluoroscopy it was noted that the stent did not release.The thumb slide was advanced again to attempt to release the stent but failed.The long delivery sheath that was already in the patient was used to successfully release the stent from the sess.The stent was deployed 2cm above the target lesion; however, was partially deployed within the target lesion.The sess was removed under fluoroscopy.A 5x40mm supera stent was deployed to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10963009
• MDR Text Key: 220965710
• Report Number: 2024168-2020-10246
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 42045040-120
• Device Lot Number: 0012361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1