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

Catalog Number S-55-060-120-P6

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during unpacking of a 5.5x60 mm supera stent system a hair was noted to be embedded in the tray underneath the device protective tubing of the device.The device packaging was noted to be completely sealed prior to opening the device.The device was not used and there was no patient involvement.A new same sized supera stent was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4)./ evaluation summary: unique device identifier (udi): (b)(4).The device was returned for evaluation.The reported hair inside the package was able to be confirmed.A review of the electronic lot history record (elhr) for the reported lot revealed no nonconforming material records (ncmrs), indicating all lot release testing met specifications.A query of the complaint-handling database indicated there were no similar incidents reported from this lot for this issue.In this case, there were no untoward patient effects since the device was not used on a patient and the issue was detectable prior to the procedure.Based on the information reviewed for this lot, it was determined that this was an isolated incident and not representative of the entire lot.This type of reported event will continue to be monitored per local quality system procedures.

Manufacturer Narrative

(b)(4).

• 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): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5207931
• MDR Text Key: 30843604
• Report Number: 2024168-2015-06632
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 02399058
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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