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

Catalog Number	1012535-60
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was returned.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 procedure was to treat a mildly tortuous and calcified lesion in the left external iliac artery.The 7.0x60mm absolute pro self expanding stent system (sess) was advanced without resistance to the lesion.During deployment, resistance was met rotating the thumbwheel, resulting in difficulties deploying the stent.The thumbwheel and shaft had to be torqued in order to completely deploy the stent.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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.Visual and functional analysis was performed on the returned device.It was noted that the sheath was separated from the outer member at the proximal end of the sheath but was still intact.The reported difficulties were unable to be confirmed due to the condition of the returned device.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 due to procedural circumstances.It is likely that the distal shaft was bent or restricted in the anatomy causing the noted damage and preventing the shaft lumens from moving freely resulting in resistance with the thumbwheel and deployment difficulty.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: 9489614
• Report Number: 2024168-2019-14689
• Device Sequence Number: 13517645
• Product Code: NIP
• UDI-Device Identifier: 08717648176074
• UDI-Public: 08717648176074
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/14/2020

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: 08/31/2022
• Device Catalogue Number: 1012535-60
• Device Lot Number: 9091961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/11/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1