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

Model Number	1012530-80
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the endovascular iliac stent procedure was performed to treat a lesion in the iliac artery with no calcification, no tortuosity and 70% stenosis.The 8.0x80mm absolute pro self expanding stent system (sess) was advanced to the lesion.During deployment, the stent partially deployed in the introducer sheath and the thumbwheel wouldn¿t move.The stent was thought to be fully deployed in the vessel under fluoroscopy; however, when the catheter was being removed, resistance was met with the introducer sheath as well as with the guide wire and the stent.The catheter was removed.When the wire was attempted to be removed, the wire did not want to come out of the sheath.The wire and sheath were removed, and it was found that the stent was attached to the sheath and was also removed.Another unspecified device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure, mechanical jam and difficult to remove introducer sheath were unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to remove guide wire was unable to be confirmed.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 during deployment the stent inadvertently partially deployed into the introducer sheath; thus compromising the device resulting in the reported thumbwheel difficulties and the reported difficult to remove difficulties with the introducer sheath and the guide wire.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: 16694143
• Report Number: 2024168-2023-03564
• Device Sequence Number: 7362933
• Product Code: NIP
• UDI-Device Identifier: 08717648175725
• UDI-Public: 08717648175725
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 1012530-80
• Device Catalogue Number: 1012530-80
• Device Lot Number: 3022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-ABBOTT 035 GUIDE WIRE
• Patient Age: 68 YR
• Patient Sex: Female