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

Catalog Number 42055150-120

Device Problems Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified de novo right superficial femoral artery that was 80% stenosed.Pre-dilatation was performed with a 6x80mm armada 35 balloon.While advancing the supera to the target lesion, there was some resistance met with a non-abbott sheath and an asahi guide wire, but the supera ultimately reached the lesion.During deployment, the thumbslide was difficult to push; once it was pushed harder the thumbslide was able to move but the stent implant only partially deployed (a portion was noted to be deployed in the introducer sheath).The supera was removed independently under fluoroscopy.A new supera stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 related to circumstances of the procedure.It is likely that anatomical conditions contributed to the reported difficulty advancing as the anatomy was described as mildly tortuous, heavily calcified and 80% stenosed.Additionally, it is likely that the distal sheath of the delivery system was bent or entrapped in the challenging anatomy preventing the ratchet from engaging the stent properly resulting in difficulty advancing the thumbslide and partial deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 13360925
• MDR Text Key: 288891439
• Report Number: 2024168-2022-00869
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

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: 02/28/2023
• Device Catalogue Number: 42055150-120
• Device Lot Number: 1032261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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: ASAHI GAIA PV 0.018 WIRE.; TERUMO 0.035 GUIDE WIRE.; TERUMO 6 FR. SHEATH.