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

Catalog Number SE-04-080-120-6F

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 10/29/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a totally occluded, heavily calcified and 100% stenosed proximal femoral artery.Pre-dilatation was performed with a 2 mm unknown balloon catheter and then a 4.0 x 120 mm armada balloon catheter.An unknown size, supera stent was implanted without issue.As a 4.0 x 80 mm supera was implanted, the stent delivery system tip became stuck in the partially deployed stent and the tip separated and was jailed under the stent.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported difficult to remove could not be confirmed as it was based on case circumstance.The tip separation was confirmed.A review of the job traveler revealed no non-conformances.The results of the historical data review and query of the complaint handling database revealed no other incidents reported from this lot.Per the supera instructions for use (ifu) reference vessel diameter (rvd) should be >4.6mm for outer diameter (od) of selected 6mm stent.The cine of the procedure was reviewed by an abbott vascular clinical specialist who concluded that the images showed stent elongation and tip detachment was due to improper vessel preparation / stent sizing.Improper vessel preparation and stent sizing per ifu for 4mm selected stents resulted in stent elongation and reduced stent lumen.The tip detached inside the deployed stent due to under-prepared vessel diameter for the tip, delivery system sheath and partially deployed stent.When the resistive forces overcame the tip lumen strength, the tip lumen detached from the ratchet assembly and jailed in the stent.Based on the reviewed information, no product deficiency was identified.

• Brand Name: SUPERA PERIPHERAL 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 462
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4270100
• MDR Text Key: 5226314
• Report Number: 2024168-2014-07691
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: SE-04-080-120-6F
• Device Lot Number: 02354053
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR