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

Model Number 1012535-60

Device Problems Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.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 reported from this lot.The investigation was unable to determine a definitive cause for the difficulties.According to the reported information, it may be possible that the distal shaft was restricted in the anatomy preventing the shaft lumens from moving freely preventing deployment and causing the thumbwheel to have resistance.Ultimately, the stent was deployed successfully with the reported absolute device.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 performed to treat a heavy calcified lesion in the iliac artery.A 7.0x60mm absolute sess was advanced and successfully deployed; however the thumbwheel had minor resistance.There were no adverse patient effects and no clinically significant delay in the procedure.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 10467491
• MDR Text Key: 204900792
• Report Number: 2024168-2020-07213
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176074
• UDI-Public: 08717648176074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2020

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: 08/31/2022
• Device Model Number: 1012535-60
• Device Catalogue Number: 1012535-60
• Device Lot Number: 9092361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 120