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

Catalog Number SE-06-060-120-6F

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

Reportedly, the tip of 6x60mm supera device broke off in the patient vessel.A snare was used to successfully remove it.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspections were performed on the returned device.The tip detachment was confirmed.In this case, it may be possible that failing to retract the thumbslide prior to withdrawal caused the tip separation; however, this could not be 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 other incidents.The investigation was unable to determine the cause for the reported tip detachment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 6642135
• MDR Text Key: 77603215
• Report Number: 2024168-2017-05075
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: SE-06-060-120-6F
• Device Lot Number: 6121361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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
• Patient Outcome(s): Required Intervention