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

Model Number	1012536-80
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The investigation was unable to determine a conclusive cause for the reported difficulties.It is possible that the device interacted with the anatomy and the balloon catheter during the procedure resulting in the reported difficult to remove.During the removal attempt the device interacted further with the guiding catheter and anatomy, resulting in the reported stent material deformation; however, without the device to examine, this cannot be confirmed.The surgical procedure in order to remove the delivery catheter and the remaining portion of the stent as based on case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling.Na.
Event or Problem Description
It was reported that this was a procedure to treat a right common iliac artery.An absolute pro 8x80x135 self expanding stent (ses) was inserted and deployed.However, when removing the balloon catheter, it was noticed the stent had become caught on the catheter.When the delivery catheter was removed from the anatomy, it was observed the stent had become stretched and 1/2 of it had come out of the anatomy while removing the catheter.Therefore, the physician made the decision to transfer the patient to surgery and remove the delivery catheter and the remaining portion of the stent.No additional information as provided.

• Brand Name: ABSOLUTE PRO VASCULAR
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11445999
• Report Number: 2024168-2021-01861
• Device Sequence Number: 3618781
• Product Code: NIP
• UDI-Device Identifier: 08717648176166
• UDI-Public: 08717648176166
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 07/31/2023
• Device Model Number: 1012536-80
• Device Catalogue Number: 1012536-80
• Device Lot Number: 0082561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 53