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

Catalog Number 42055150-120

Device Problems Premature Activation (1484); Product Quality Problem (1506)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

It was reported when the physician removed the supera stent from the packaging, it was observed the device was unlocked and deployed.Therefore, the device was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initial information, the returned device analysis reported the stent was deployed and the device was returned with blood on the inner member of the device.The inner member separated 0.5cm proximal to the distal end of the jacket.

Manufacturer Narrative

The device has been returned, but the investigation is not yet completed.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned for analysis.The reported irregular appearance and the reported premature activation were unable to be replicated in a testing environment due to the condition of the returned device.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 from this lot.It was reported that when the physician removed the supera stent from the packaging it was observed the device was unlocked and deployed.Therefore, the device was not used and was replaced.However, the device was returned with blood and contrast visible inside the inner member consistent with advancement/use.An initial follow up to the account confirmed the correct device was returned; however an additional follow up to the account confirmed there is a possibility that the product that was returned was the one implanted (instead of the complaint device).As such, as the noted device condition and the noted device damages (pinched sheath, separated inner member) are inconsistent with the reported difficulties, the investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 14474269
• MDR Text Key: 292494307
• Report Number: 2024168-2022-05513
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 42055150-120
• Device Lot Number: 0021761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2020
• 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