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

Model Number	1012534-20
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 of the reported lot revealed no other similar incidents.Without having the device to examine, a cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified, non-tortuous iliac artery.During deployment of the 6.0x20mm absolute pro self-expanding stent system, the stent became exposed (not flowered) and didn't deploy as the thumbwheel would not turn.Upon removal, the tip was noted to be bent.A new unspecified stent was deployed to successfully 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
Nana.
Event or Problem Description
The following additional information was received subsequent to filing the final mdr: the case was a femoral to femoral crossover.No additional information was provided.

• 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
• MDR Report Key: 9722588
• Report Number: 2024168-2020-01584
• Device Sequence Number: 11362956
• Product Code: NIP
• UDI-Device Identifier: 08717648175961
• UDI-Public: 08717648175961
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: 04/30/2022
• Device Model Number: 1012534-20
• Device Catalogue Number: 1012534-20
• Device Lot Number: 9052061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR