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

Catalog Number	1012534-30
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
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.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.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous and heavily calcified left external carotid artery.A 60 x 30 mm absolute pro vascular self-expanding stent system was used and met initial resistance with the sheath during advancement.However, before reaching the target, it was observed under flouroscopy that there was no stent on the balloon.The device was pulled back, and the stent had prematurely deployed in the sheath.A part of the stent was sticking out of the sheath.The device was then removed as a single unit with sheath without any issues.The device did not separate into two separate pieces.The procedure was successfully completed with a non-abbott stent.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 to treat a heavily tortuous and heavily calcified left external carotid artery.A 6.0 x 30 mm absolute pro vascular self-expanding stent system was used and met initial resistance with the sheath during advancement.However, before reaching the target, it was observed under fluoroscopy that there was no stent on the balloon.The device was pulled back, and the stent had prematurely deployed in the sheath.A part of the stent was sticking out of the sheath.The device was then removed as a single unit with sheath without any issues.The device did not separate into two separate pieces.The procedure was successfully completed with a non-abbott stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The report difficult to advance and premature activation were not confirmed as the sess was advanced through a proxy introducer sheath without any resistance noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the event.Additionally, a review of the complaint history identified no other incidents.The investigation determined that the reported difficulties were likely due to case related circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Exemption number e2019001.

• 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: 8911627
• Report Number: 2024168-2019-10980
• Device Sequence Number: 16203434
• Product Code: NIP
• UDI-Device Identifier: 08717648175978
• UDI-Public: 08717648175978
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/23/2019

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: 03/31/2020
• Device Catalogue Number: 1012534-30
• Device Lot Number: 7040361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1