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

Catalog Number 42055060-120

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis and the stent was identified to be dislodged.The reported difficult to insert the guide wire was unable to be confirmed.As the reported difficult to insert guide wire was unable to be confirmed, a follow up to the account confirmed the correct device was returned.Additionally, regarding the noted stent not being present on the device, the account stated they did not do anything with the device after the issue.It is likely that during packaging and/or during shipment for device analysis inadvertent mishandling resulted in the stent inadvertently deploying/dislodging.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 incidents from this lot.The investigation determined a conclusive cause for the reported difficult to insert the guide wire cannot be determined.As the reported difficult to insert the guide wire was unable to be confirmed during return analysis, it is possible that a coagulation of blood and/or contrast on the guide wire resulted in the reported difficulties; however this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during preparation, after inserting the guidewire roughly 10cm into the supera 5.5x60, resistance was felt and was unable to advance through the stent.The guide wire was removed, and the stent was flushed.The guide wire was reinserted, but resistance was felt again.Therefore, the stent was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.When the device was returned, the stent was not present; therefore, it is presumed the stent dislodged.

• 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: 13259318
• MDR Text Key: 284192807
• Report Number: 2024168-2022-00523
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 01/14/2022

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: 06/30/2023
• Device Catalogue Number: 42055060-120
• Device Lot Number: 1071561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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: GUIDE WIRE