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

Catalog Number 1012015-150

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270); Noise, Audible (3273)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported during the procedure the 6.0x150mm absolute pro self expanding stent (ses) was advanced over an unspecified 0.018 guide wire to the target lesion.A small amount of resistance was felt while pushing the thumb wheel yet it stopped spinning and a snap sound was heard.The stent only partially deployed and was removed from the anatomy, noting some stent fragments remain in the patient.There was no reported adverse patient sequela and no reported clinically significant delay.No additional information was provided.

Manufacturer Narrative

H6- medical device problem code 2017 - failure to follow steps / instructions.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, a.018 guide wire was used.It should be noted the absolute pro ll peripheral self-expanding stent system instructions for use (ifu) states: one 0.035¿ (0.89 mm) diameter guide wire.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that use of the undersized.018¿ guide wire resulted in the distal shaft to be bent in the anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam and the reported activation/deployment failure.Manipulation of the compromised device in attempts to deploy the stent by pushing the thumbwheel resulted in the reported noise/snap sound heard as the thumbwheel gears were binding.As reported, the stent only partially deployed and was removed from the anatomy, noting some stent fragments remain in the patient.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO LL 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: 18944727
• MDR Text Key: 338184958
• Report Number: 2024168-2024-03564
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648130212
• UDI-Public: (01)08717648130212(17)261031(10)3112162
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110028
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012015-150
• Device Lot Number: 3112162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2023
• 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: UNSPECIFIED 0.018 GUIDE WIRE
• Patient Outcome(s): Required Intervention