MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	S-45-120-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The difficulty advancing the guide wire and damage to the tip were unable to be confirmed due to the condition of the returned device.The distal end of the sheath was smashed.The tip was separated from the inner member.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported difficulties.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 4.5x120 mm supera stent delivery system (sds) was loaded on the guide wire, but it could not be advanced into the body.The sds was removed from the guide wire and the guide wire was wiped down.They reloaded the sds on to the same guide wire, but still could not advance it.It was then noted that the distal end of the sds was unraveled.The sds was again removed from the guide wire.A 5.5 mm supera was prepared and was able to advance over the same guide wire without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.Device analysis found that the tip of the sds had separated.

• Brand Name: SUPERA 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: 8479421
• Report Number: 2024168-2019-02601
• Device Sequence Number: 1612185
• Product Code: NIP
• UDI-Device Identifier: 08717648226007
• UDI-Public: 8717648226007
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• 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): 04/03/2019

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: 09/30/2020
• Device Catalogue Number: S-45-120-120-P6
• Device Lot Number: 8100461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1