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

Model Number 1012530-40

Device Problems Difficult or Delayed Positioning (1157); Premature Activation (1484)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat an unknown lesion.An 8.0x40mmx80cm absolute pro vascular self-expanding stent system (sess) was advanced to the target lesion; however, the position of the stent was not confirmed via imaging.The thumbwheel was slightly turned, and the shaft moved; however, it was unknown whether the stent was deployed or not.The stent delivery system was removed from the anatomy.The physician did not see the stent edge, but it was apposed to the vessel wall and the entire stent was deployed and implanted at an unintended site.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Date of event ¿ estimated, date of implant ¿ estimated.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to the initial medwatch report, the following information was received: it was reported that the procedure was to treat a moderately calcified, moderately tortuous, 90% stenosed lesion in the external iliac artery.An 8.0x40mmx80cm absolute pro vascular self-expanding stent system (sess) was advanced to the target lesion; however, the thumbwheel was slightly turned, and the shaft moved resulting in the stent deploying within the target lesion, with the edge of the stent outside of the target lesion.The position of the stent was hard to see due to the anatomy and the thin profile of the stent.The stent delivery system was removed from the anatomy.The stent was noted to be well apposed to the vessel wall.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure, as it is likely that due to the moderately calcified, moderately tortuous and 90% stenosed anatomy, that the position of the stent was unable to be confirmed resulting in the reported difficult or delayed positioning.During deployment interaction with the moderately calcified, moderately tortuous and 90% stenosed anatomy resulted in the shaft moving thus resulting in the reported premature activation (stent edge outside of the target lesion).There is no indication of a product quality issue with respect to manufacture, design or labeling.B1, b2, h2: new information changed report from a serious injury report to a malfunction.B3: date of event, h6: health effect - clinical code 2687 - removed, h6: health effect - impact code 4614 - removed.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 16142390
• MDR Text Key: 307152902
• Report Number: 2024168-2023-00433
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648175701
• UDI-Public: 08717648175701
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1012530-40
• Device Catalogue Number: 1012530-40
• Device Lot Number: 0060961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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
• Patient Outcome(s): Other