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

Model Number	1012536-80
Medical Device Problem Codes	Entrapment of Device (1212); Off-Label Use (1494); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the transverse sinus with moderate tortuosity.A non-abbott 6f guide wire was used first but failed.Another non-abbott device was advanced through the guide sheath.The absolute pro self expanding stent system (sess) was advanced and resistance was noted with the anatomy.The angles around the lesion caused some resistance and pressure on the delivery system.The sheath was pulled back to expose the stent; however, the stent was partially deployed (approximately 20 mm) and the thumbwheel wouldn't move.At this point, the stent failed to deploy and the sess could not be removed.The handle was removed and surgical cut down was performed to retrieve device from the anatomy.There was a one hour delay in the procedure due to the need for surgery and the patient was hospitalized one additional day.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 1494 - incorrect anatomy.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and the reported mechanical jam were unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to advance and the reported entrapment of device were unable to be replicated in a testing environment as they were based on operational circumstances.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 device was used in the sinoatrial nodal artery.It should be noted that the absolute pro vascular self-expanding stent system instructions for use (ifu) states: the absolute pro vascular self-expanding stent system is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery.It is undetermined if the deviation of the instructions for use caused/contributed to the reported difficulties.As there was no damage noted to the device during the inspection prior to use, 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 moderate torturous anatomy resulting in the reported difficult to advance.Additionally, the moderate torturous anatomy/angles around the lesion resulted in the distal shaft to be bent preventing the shaft lumens from moving freely, resulting in resistance with the thumbwheel/ mechanical jam and difficulty deploying the stent/ activation failure.Interaction with the anatomy and/or other devices resulted in the reported entrapment of device.Manipulation of the device during attempted removal, in conjunction with removing/opening the handle, resulted in the multiple noted device damages.The treatments appears to be related to the operational context of the procedure as surgical cut down was performed to retrieve device from the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 16845150
• Report Number: 2024168-2023-04514
• Device Sequence Number: 15330534
• Product Code: NIP
• UDI-Device Identifier: 08717648176166
• UDI-Public: 08717648176166
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 1012536-80
• Device Catalogue Number: 1012536-80
• Device Lot Number: 0120361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 107 KG