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

Catalog Number SE-05-100-120-6F

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  Injury  

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 received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a femoral artery.A 5.0 x 100 mm supera self-expanding stent was deployed without issue.When the delivery catheter was being removed, there was resistance with a previously placed non-abbott stent and the tip of the catheter separated and was removed with a snare device.Although the procedure took an extra 15-20 minutes, it was reported that the delay was not clinically significant.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device.The tip separation was confirmed.The difficulty removing was not confirmed due to the condition of the returned device.A review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4).A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.

• 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: 7307657
• MDR Text Key: 101312675
• Report Number: 2024168-2018-01490
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: SE-05-100-120-6F
• Device Lot Number: 6060261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 03/20/2018; 03/26/2018
• Supplement Dates FDA Received: 03/26/2018; 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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