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

Catalog Number 42055080-120

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.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 incidents.The investigation determined that the reported deployment difficulty and stent shortening were likely the result of anatomical challenges.Forward/pushing motion on the delivery system during stent deployment while attempting to place in the 90% stenosed, moderately tortuous, heavily calcified lesion may have caused shortening of the stent.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 90% stenosed, moderately tortuous, and heavily calcified lesion in the superficial femoral artery.A 6fr 45cm sheath was advanced through the 5.5mm vessel.Following pre-dilatation with a 5.5x80mm armada 18 balloon catheter, a 5.5x80mm supera self-expanding stent system (sess) was advanced.During deployment of the sess the stent became compressed greater than 10% and did not cover the entire lesion.The stent remained within the target lesion and the delivery system was removed under fluoroscopy.A 5.5x100mm supera stent was deployed overlapping the existing stent to fully cover the lesion.The patient is doing fine.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SUPERA PERIPHERAL 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: 9824677
• MDR Text Key: 183158608
• Report Number: 2024168-2020-02336
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 42055080-120
• Device Lot Number: 9061361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• 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
• Treatment: GUIDE WIRE: COMMAND; SHEATH: 6FR CROSS OVER LENGTH 45CM
• Patient Age: 65 YR
• Patient Weight: 80