MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1011921-060

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

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.In this case, the stent was not prematurely deployed or flowered as reported.However, the stent was moved slightly distal within the sheath.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 complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulty.The stent was not prematurely deployed or flowered as reported.However, the stent was moved slightly distal within the sheath.Based on the reported information and analysis of the returned unit, it is possible that during removal of the stylet, the tip was inadvertently pulled such that the stent moved distally within the sheath; however, this could not 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 device preparation and before use, the stent delivery system had an abnormal appearance; the stent may have been partially deployed/flowered.There was no patient involvement and no clinically significant delay in the procedure.A new absolute pro was used to complete the procedure.No additional information was provided.Device analysis noted that the stent was dislocated on the delivery system.

• Brand Name: ABSOLUTE PRO .035 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: 12389497
• MDR Text Key: 268956672
• Report Number: 2024168-2021-07666
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/30/2021

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: 02/28/2022
• Device Catalogue Number: 1011921-060
• Device Lot Number: 9031861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• 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