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

Catalog Number SE-04-040-120-6F

Device Problems Difficult or Delayed Positioning (1157); Physical Resistance (2578); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

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.Estimated date.The stent delivery system is not returning.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported as a general comment that 4 x 40 mm supera self-expanding stents (ses) have deployment issues.Resistance is met with the anatomy during advancement.The ses will partially deploy and the deployment system will fail to work.Several attempts are made to deploy the ses.The deployment lock opens and the delivery system is pulled back to deploy the remainder of the stent, pushing it to avoid elongation.The stent will elongate to 10%.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.It may be possible that the reported resistance and deployment issue were related to anatomical conditions.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.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.

Event Description

Subsequent to the initially filed report, the following information was received: there was no adverse patient sequela and no reported clinically significant delay in any procedure or therapy.

• 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
• MDR Report Key: 7347511
• MDR Text Key: 103155544
• Report Number: 2024168-2018-01935
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SE-04-040-120-6F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1