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

Catalog Number 1011917-080

Device Problems 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 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

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 similar incidents from this lot.Reportedly, a.014¿ guide wire was used.It should be noted the absolute pro peripheral self-expanding stent system instructions for use (ifu) states: use a 0.035¿ (0.89 mm) diameter guide wire with the absolute pro.035 peripheral self-expanding stent system.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.It is undetermined if the deviation of the ifu caused/contributed to the reported difficulties.It is possible that a coagulation of blood/contrast on the guide wire and/or use of the undersized.014¿ guide wire resulted in compromising the device; thus resulting in the reported difficult to advance and the reported difficult to remove; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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 mildly tortuous, moderately calcified iliac artery.The 8.0x80mm absolute pro self-expanding stent system (sess) was attempted to advanced; however, the shaft became stuck on the unspecified 014 guide wire during advancement.It was noted that initially the device could not be removed; however, the device was removed independently eventually.Another absolute pro was used to successfully complete the procedure.There was no adverse patient effects reported 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: 18610335
• MDR Text Key: 334541856
• Report Number: 2024168-2024-01227
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011917-080
• Device Lot Number: 2111661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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
• Treatment: 014 GUIDE WIRE