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

Catalog Number 1012535-100

Device Problems Off-Label Use (1494); Defective Device (2588)

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

Event Date 07/14/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the left circumflex artery (lcx).Pre-dilatations were performed using different sized armada 18 balloons without issues.It was noted that the stent of the 7.0x100mm absolute pro vascular self-expanding stent system (sess) looked longer than what it should be and it looked more like a 120mm.Therefore, the device was removed from the patient.The procedure was completed with another 80mm absolute pro stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was returned for analysis.The reported defective device ¿ oversized stent was unable to be confirmed.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.As the reported defective device - oversized stent was unable to be confirmed during return analysis, it is possible that in the anatomy the stent length visually under fluoroscopy was erroneously measured incorrectly; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Inadvertent mishandling likely resulted in the noted wrinkled sheath.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

H6: medical device problem code 1494 - incorrect anatomy.Reportedly, the procedure was to treat a lesion in the left circumflex artery.It should be noted the absolute pro vascular self-expanding stent system instructions for use states: the absolute pro vascular self-expanding stent system is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm and 9.1 mm and lesion lengths up to 90 mm.H6: medical device problem code 1494 added.

• 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: 17450719
• MDR Text Key: 320348966
• Report Number: 2024168-2023-08386
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176098
• UDI-Public: 08717648176098
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

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 Catalogue Number: 1012535-100
• Device Lot Number: 2060962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/17/2023; 02/14/2024
• Supplement Dates FDA Received: 09/06/2023; 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG