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

Catalog Number S-50-060-120-P6

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 12/25/2018

Event Type  malfunction  

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.Evaluation summary: visual inspection was performed.The reported foreign material in the packaging was confirmed.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 indication of a lot specific product issue.The investigation determined the foreign material inside the unopened pouch appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Event Description

It was reported that during an incoming inspection at the distribution center, a 5.0 x 60 mm supera self expanding stent system (sess) was rejected for foreign material in the packaging.There were no reported problems with the sterility of the device.As the cosmetic non-conformity was noted at the distribution center there was no patient involvement.The sess unit were not used.No additional information was provided.Returned goods analysis identified that the foreign material in the packaging was a manufacturing component.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8587737
• MDR Text Key: 144317781
• Report Number: 2024168-2019-03606
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211744
• UDI-Public: 08717648211744
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: S-50-060-120-P6
• Device Lot Number: 8082361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1