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

Catalog Number 1011922-100

Device Problems Break (1069); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

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

Event Date 04/28/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the iliac artery with 85% stenosis, calcification and tortuosity.The access was through the radial artery.The 7.0x100mm absolute pro 0.35 self-expanding stent system (sess) had resistance with the anatomy and force was used but within reasonable limits.The sheath broke off from the delivery system but was not in two separate parts.The delivery system was caught on the introducer during deployment and the entire delivery system along with the sheath and introducer were removed together as a unit.An additional puncture of the ipsilateral femoral artery for retrograde balloon angioplasty was performed in order to perform pre-dilatation of the iliac artery stenosis and position a stent.There was no adverse patient effect.Although there was reported delays in the procedure, it was confirmed that there were no adverse patient effects; therefore the delay is not considered clinically significant.No additional information was provided.

Manufacturer Narrative

H6: medical device problem code 2017/excessive force.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 7.0x100mm absolute pro 0.35 self-expanding stent system (sess) had resistance with the anatomy and force was used but within reasonable limits and the sheath broke off from the delivery system but was not in two separate parts.It should be noted that the absolute pro.035 peripheral self-expanding stent system instructions for use states: should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.Although it was noted the physician used force in the attempts to advance the device, the force applied seemed to be a reasonable clinical response to the difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the calcified, torturous and 85% stenosed anatomy resulting in the reported difficult to advance.Interaction/manipulation of the device using reasonable force inadvertently resulted in the reported sheath break; thus ultimately resulting in the reported difficult to remove as the compromised delivery system was caught on the introducer.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 16975358
• MDR Text Key: 315710452
• Report Number: 2024168-2023-05430
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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
• Report Date: 05/22/2023

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: 1011922-100
• Device Lot Number: 1081861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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