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

Model Number	1012538-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified iliac artery.A 10x100mm absolute pro self-expanding stent system (sess) felt resistance from the anatomy but was advanced to the target lesion successfully, and the stent was implanted.The delivery system faced resistance with the anatomy during removal, and the proximal shaft separated.The device was simply withdrawn, and the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified iliac artery.A 10x100mm absolute pro self-expanding stent system (sess) felt resistance from the anatomy but was advanced to the target lesion successfully, and the stent was implanted.The delivery system faced resistance with the anatomy during removal, and the proximal shaft separated.The device was simply withdrawn, and the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the proximal shaft of the 10x100mm absolute pro self-expanding stent system (sess) did not separate, but the shaft jacket was the portion that separated.No portion of the device remains in the patient.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The difficulties were unable to confirmed due to the condition of the returned device.It should be noted that the absolute pro instruction for use, states: should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.In this case, the difficulties encountered resulting in removing with force were related to procedural 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.The investigation determined that the reported difficulties appear to be related to procedural circumstances.It is likely that the resistance during advancement and removal was due to interaction with the heavily calcified lesion.Additionally, during removal against resistance, the shaft jacket damage occurred.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9369220
• Report Number: 2024168-2019-13849
• Device Sequence Number: 14213842
• Product Code: NIP
• UDI-Device Identifier: 08717648176319
• UDI-Public: 08717648176319
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 07/31/2020
• Device Model Number: 1012538-100
• Device Catalogue Number: 1012538-100
• Device Lot Number: 7082161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1