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

Catalog Number	1012528-40
Medical Device Problem Codes	Difficult to Insert (1316); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.The initial device analysis identified a fracture of the device component, but the investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the 6.0x40 mm absolute pro vascular self expanding stent system (sess) was intended to reach the distal basilic vein.The sess was loaded on to the guide wire without incident, but it could not enter the radial vein access site.A closer look of the sess was taken at that time and it was noted that the stent struts were mangled.The sess was removed and replaced with a non-abbott device.The non-abbott device was used to complete the procedure without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis found that the inner member and the stent holder were separated 4mm proximal to the distal marker.
Additional Manufacturer Narrative
Exemption number e2019001.Visual and dimensional analysis was performed on the returned device which identified an inner member separation.The reported difficult insertion was not tested due to the condition of the returned device.The reported stent damage was 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 revealed no other complaints.The investigation determined that the reported difficulties were related to procedural circumstances.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: 9279388
• Report Number: 2024168-2019-13209
• Device Sequence Number: 2801450
• Product Code: NIP
• UDI-Device Identifier: 08717648175541
• UDI-Public: 08717648175541
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 1012528-40
• Device Lot Number: 9010761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 10/12/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68