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

Catalog Number	1012537-100
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The absolute pro stent system was returned and visual analysis was performed on the returned device.The handle of this device was opened to inspect the mechanical components and found no anomalies.The reported issue was unable to be confirmed as the stent remains in the patient.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported information of the distal end of the stent being narrowed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Evaluation summary: the investigation was unable to determine a conclusive cause for the reported information of the distal end of the stent being narrowed.It is possible that anatomical conditions prevented the distal end of the stent from being able to fully expand; however, this could not be confirmed.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 the 9.0x100 mm absolute pro vascular stent was deployed in the pre-dilated, right external iliac via the radial artery access site.After the stent was deployed, the distal end of the stent was narrowed.The physician felt this was a device issue and not related to the lesion itself.An 8.0x80 mm armada 35 balloon dilatation catheter was advanced through the stent lumen to post dilate the absolute pro stent and fully expand the distal end of the stent.A herculink elite stent was also deployed on the distal end of the absolute pro stent to keep it open.No additional information was provided.

• 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: 8532157
• Report Number: 2024168-2019-03111
• Device Sequence Number: 11224166
• Product Code: NIO
• UDI-Device Identifier: 08717648176258
• UDI-Public: 08717648176258
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 1012537-100
• Device Lot Number: 7120161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 69