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

Catalog Number 1011915-060

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Difficult to Advance (2920)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an unspecified vessel.The 6x60 mm absolute pro self expanding stent system (sess) was intended to be placed overlapping another stent, but it became stuck in the struts and could not advance past the first implanted stent.A non-abbott stent was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficulty advancing and difficulty removing was unable to be confirmed on the returned unit as it was related to circumstances of the procedure.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 revealed no other similar complaints reported from this lot.It should be noted that the absolute pro instructions for use (ifu) states: ¿the safety and effectiveness of multiple overlapping stents have not been established.However, when multiple stents are required, stent materials should be of similar composition.¿ additionally, section 6.4 states: ¿exercise great care when crossing a newly deployed stent with a guide wire, balloon or delivery system to avoid disrupting the stent geometry.¿ in this case, it appears that interaction with the previously implanted stent while advancing distal to the stent contributed to the difficulties encountered.However, it is not known if the previously implanted stent was from a previous procedure.Based on the reported information, the difficulty advancing and difficulty removing were likely the result of interaction with the struts of the previously implanted stent.It may be possible that the previously implanted stent was not fully apposed to the vessel wall or was implanted within an angulation of the vessel resulting in the absolute pro interacting with the proximal end of the stent struts while advancing distal to the stent during advancement.When treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion.Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chances for difficulties or damage to the stent and/or delivery system.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 2524 removed.

Event Description

It was reported that the procedure was to treat the left superficial femoral artery (sfa).The 6x60 mm absolute pro self expanding stent system (sess) was intended to be placed overlapping another stent, but it became stuck in the struts and could not advance past the first implanted stent.A non-abbott stent was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Subsequent to the initially filed report the following information was provided: the stent was placed in the target lesion after difficult positioning.No additional information was provided.

• 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: 13232497
• MDR Text Key: 283760581
• Report Number: 2024168-2022-00400
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

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: 09/30/2022
• Device Catalogue Number: 1011915-060
• Device Lot Number: 9103061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2019
• 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
• Treatment: MEDTRONIC STENT.