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

Model Number	1012536-100
Medical Device Problem Codes	Break (1069); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat the moderately calcified lesion in the left iliac artery.The 8.0x100mm absolute pro self-expanding stent system (sess) was prepared per the instructions for use (ifu).The sess was being deployed per the ifu; however, the thumbwheel stopped working and the deployment couldn¿t continue.The handle was broken to fully release and deploy the stent.It looked like the end of the deployed stent was partially fractured; therefore, a non-abbott stent was deployed over it.The procedure was successfully completed.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult or delayed activation and the reported break stent were unable to be confirmed as the stent was not returned.The reported physical resistance / sticking thumbwheel was unable to be replicated in a testing environment due to the condition of the returned device.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 did not indicate a lot specific quality issue.As there was no reported damage noted to the device during the inspection prior to use the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the moderately calcified lesion and/or other devices resulted in the noted bunched stent sheath thus preventing the shaft lumens from moving freely and thus resulting in the reported physical resistance / sticking thumbwheel and the reported difficult or delayed activation.Manipulation of the device likely compromised the deployed stent resulting in the reported stent break.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: 15271497
• Report Number: 2024168-2022-09007
• Device Sequence Number: 20301383
• Product Code: NIP
• UDI-Device Identifier: 08717648176173
• UDI-Public: 08717648176173
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/28/2022

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: 10/31/2022
• Device Model Number: 1012536-100
• Device Catalogue Number: 1012536-100
• Device Lot Number: 9112261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2019
• 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: 74 YR
• Patient Sex: Male