MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	1012537-60
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	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other incidents reported from this lot.The investigation determined the reported difficulties were likely due to operational context.It is likely that the guide wire being used was damaged or kinked causing reduced clearance between the guide wire and guide wire lumen of the absolute pro.Continued movement with the absolute pro against resistance likely caused the stent to prematurely deploy.Based on the information reviewed, 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 this was a percutaneous intervention treating the external iliac.Before entering into the patient's anatomy, the absolute pro stent delivery system (sds) advanced over a guide wire.Reportedly, following insertion, resistance was felt while advancing the sds over the guide wire.Once at the sheath and before entering the anatomy, the stent had prematurely deployed as stent flowering was observed.The device was easily removed and a non-abbott device was used in replacement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8160508
• Report Number: 2024168-2018-09640
• Device Sequence Number: 2198502
• Product Code: NIO
• UDI-Device Identifier: 08717648176234
• UDI-Public: 08717648176234
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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: 08/31/2021
• Device Catalogue Number: 1012537-60
• Device Lot Number: 8092061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR