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

Catalog Number	S-55-060-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2018
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was not returned for analysis.The stent was inadvertently deployed inside the sheath; therefore, when the device was withdrawn, the stent was pulled into the sheath.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this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 determined the reported difficulties were due to operational context.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 the supera stent was advanced to the target lesion without issue.During deployment of the stent, the physician did not realize the stent was being deployed inside the sheath and the deployment lock was not unlocked; therefore, when the device was withdrawn, the stent was pulled into the sheath.The stent was encapsulated into the sheath and removed with the device without any consequences.The procedure was aborted, the lesion was treated with angioplasty only.There was no adverse patient effect 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: 7313849
• Report Number: 2024168-2018-01561
• Device Sequence Number: 1741487
• Product Code: NIP
• UDI-Device Identifier: 08975370026290
• UDI-Public: 08975370026290
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/05/2018

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: 02/28/2018
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 6031161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6FR 45 DESTINATION