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

Model Number 1012536-80

Device Problems Off-Label Use (1494); Stretched (1601); Device Damaged by Another Device (2915)

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

Event Date 06/22/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the superficial femoral artery (sfa).The patient has a previous bypass of the sfa and the ostium did not look good.The 8x80 mm absolute pro self expanding stent (ses) was deployed proximally in the sfa and an 8x18 mm absolute pro stent was deployed very distal to the first absolute pro stent.There was no issue during deployment of either device; however, it was noted that the first absolute pro stent looked stretched at the end where the marker is located.Therefore, a third absolute pro stent was deployed to overlap the first stent to cover the deformity.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.It was speculated a wire may have interacted with the stent after deployment when treating below the stent, which caused the stretching.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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.Reportedly, the procedure was to treat the superficial femoral artery (sfa).The patient had a previous bypass of the sfa and the ostium did not look good.It should be noted the absolute pro vascular self-expanding stent system instructions for use (ifu) 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.The deviation of the ifu does not appear to have caused/contributed to the reported difficulties.It is possible that after deployment, interaction with the guide wire and/or other devices resulted in the reported device damaged by another device and the reported stretched stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as a third absolute pro stent was deployed to overlap the first stent to cover the deformity.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 14991659
• MDR Text Key: 295767569
• Report Number: 2024168-2022-07573
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176166
• UDI-Public: 08717648176166
• 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
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012536-80
• Device Catalogue Number: 1012536-80
• Device Lot Number: 1100661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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: 8X18 MM ABSOLUTE PRO
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG