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

Catalog Number	S-55-150-120-P6
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/03/2018
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.The device was not returned for analysis.A cause for the reported tip detachment could not be determined.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported separation.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 when the supera package was opened and the device was removed it was noted that nosecone was separated.There was no issue during unpacking or removal of the device from the package.The device was not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

• 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: 7204207
• Report Number: 2024168-2018-00465
• Device Sequence Number: 16505905
• Product Code: NIP
• UDI-Device Identifier: 08975370026337
• UDI-Public: 08975370026337
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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: 09/30/2019
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 7100561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1