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	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional armada device is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified left superficial femoral artery (sfa).A 5.0x40mm armada 35 was attempted to be advanced; however, failed as resistance was met with anatomy.Another different size armada was used to successfully cross the lesion and dilate the lesion.A 8.0x100mm absolute pro self expanding stent system (sess) was advanced and once ready to deploy the thumbwheel would not turn.The sess failed to deploy and once removed the physician tried to deploy the device, but the thumbwheel would still not turn.Another absolute pro was used to complete the procedure.There were no patient adverse effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported deployment issue was confirmed.The reported mechanical jam was confirmed.There was a noted outer member separation from the distal sheath.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 similar incidents reported from this lot.The investigation was unable to determine a cause for the difficulties.It may be possible that the distal shaft was bent or restricted in the anatomy preventing the shaft lumens from moving freely and causing resistance with the thumbwheel; however, this could not be confirmed.The noted outer member separation from the distal sheath was likely cause by case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 11571581
• Report Number: 2024168-2021-02406
• Device Sequence Number: 3898561
• Product Code: NIP
• UDI-Device Identifier: 08717648176173
• UDI-Public: 08717648176173
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/20/2021

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: 06/30/2023
• Device Model Number: 1012536-100
• Device Catalogue Number: 1012536-100
• Device Lot Number: 0071361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR