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

Catalog Number	S-55-100-120-P6
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2018
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 returned for analysis and the reported white color of the flush port was confirmed.Visual analysis confirmed that the flush port was the correct size; however, during functional testing, a syringe was unable to be connected to the flush port due to the reported white substance.Chemical analysis was performed and determined the white substance to be loctite adhesive.A review of the lot history record revealed no manufacturing nonconformities reported on this lot.A review of the complaint history identified no other incidents reported from this lot.Based on this evaluation, a potential product quality issue has been identified.The potential product issue will be addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the flush port of the supera delivery catheter was shorter, did not have threading, and was a milky, white color.This device was not used in the body.Another supera was used to complete the procedure.There was no additional information provided.Device analysis identified a white substance inside the flush port of the returned device.
Additional Manufacturer Narrative
(b)(4).

• 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: 7310970
• Report Number: 2024168-2018-01530
• Device Sequence Number: 13768316
• Product Code: NIP
• UDI-Device Identifier: 08975370026313
• UDI-Public: 08975370026313
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: S-55-100-120-P6
• Device Lot Number: 7081761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1