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

Catalog Number 42065200-120

Device Problems Stretched (1601); Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2021

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 complaints reported from this lot.The investigation determined that the reported difficulties were due to case circumstances.It is likely that the distal sheath of the delivery system was entrapped or bent in the anatomy such that the ratchet was unable to properly engage the stent resulting in deployment difficulty.The elongation was likely the result of manipulating the delivery system with the stent partially deployed.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 to treat the iliac artery.The vessel diameter was 5.5 mm and atherectomy was not used.The lesion was prepared with a balloon and a 6fr sheath was used.The 6.5x200 mm supera self expanding stent system (sess) partially deployed about 3/4 due to the delivery system being stuck and then elongated the rest of the way and is located in the target lesion.A 6.5x150 mm absolute pro sess flowered out a quarter of the way and then stopped and could not be deployed more but the thumbwheel was at maximum and the stent was only half way deployed.It was stated the thumbwheel was broken.The physician pulled apart the handle to remove the stent and delivery system.Non-abbott stents were used to complete the procedure.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and functional analysis was performed on the returned device.The reported partial deployment and difficulty advancing the thumbslide was confirmed.The stent elongation was not confirmed.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 complaints reported from this lot.The investigation determined that the reported difficulties were due to case circumstances.It is likely that the distal sheath of the delivery system was entrapped or bent in the anatomy such that the ratchet was unable to properly engage the stent preventing movement of the thumbslide and resulting in deployment difficulty.The elongation was likely the result of manipulating the delivery system with the stent partially deployed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9/h3 return status changed from no to yes.H10: type of investigation code 4115 removed.

• 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: 13501842
• MDR Text Key: 288786226
• Report Number: 2024168-2022-01363
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 42065200-120
• Device Lot Number: 1080961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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: COMMAND GUIDE WIRE