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

Catalog Number 1011920-080

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual and functional inspection was performed on the returned device.The premature deployment was confirmed as the device was returned with the stent exposed at the distal end of 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 incidents reported from this lot.The delivery system preparation section of the absolute pro self-expanding stent system instruction for use (ifu) instructs: gently twist and pull to remove the tip mandrel.If the tip mandrel is not easily removed, do not use the device.The investigation determined that the exposed stent was likely due to handling.It is likely that during removal of the stylet, the tip was inadvertently pulled causing the stent to slightly pull out and become exposed.It may also be possible that the stylet was not removed per the instructions for use.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a moderately calcified, 70% stenosed lesion.Superficial femoral artery (sfa).A 5x80mm absolute pro vascular self-expanding stent system (sess) was unpacked when it was noted that the yellow sheath did not cover the distal part of the device.The yellow sheath was out of place and the device was exposed in the package.The sess was then loaded onto the guide wire (gw) but could not be advanced into the introducer sheath.The device was removed and a 5x100mm absolute pro plus a 6x80mm absolute pro stent, were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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: 12436447
• MDR Text Key: 270803709
• Report Number: 2024168-2021-07932
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K072708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2021

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: 11/30/2022
• Device Catalogue Number: 1011920-080
• Device Lot Number: 9120961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2019
• 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