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

Catalog Number SE-05-150-120-6F

Device Problems Difficult to Remove (1528); Self-Activation or Keying (1557); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2014

Event Type  malfunction  

Event Description

It was reported that the patient had a previous 6 mm non-abbott stent implanted at the proximal superficial femoral artery (sfa) but presented with the stent occluded.Using a femoral artery access approach during the procedure of the moderately calcified, mildly tortuous, proximal sfa with a reference vessel diameter measured to 5.8 mm, predilatation with a 5 mm balloon dilatation catheter at rated burst pressure was completed.During deployment of the 5 x 150 mm supera self-expanding stent system (sess), the stent elongated despite holding tightly to the deployment catheter to pack the cells together.Reportedly, under fluoroscopy the stent had emerged from the outer sheath and was released and the thumbslide was fully retracted to the start position.It was noted that the proximal end of the stent deployed in the distal end of the 6 fr sheath.The stent along with the deployment catheter were removed from the anatomy.It was noted under fluoroscopy that the vessel had good flow in the sfa and the physician chose to perform no further intervention and no stent placement.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4) - failure to follow steps; pre-dilatation vessel size.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported deployment difficulty, stent elongation, stent damage, and difficulty removing could not be confirmed as they were based on circumstances during the procedure.The reported tip detachment was confirmed.A review of job traveler revealed no non-conformances that would have contributed to the reported event.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 instruction for use (ifu) the recommended pre-dilatation diameter for a 5.0 mm stent is greater than 5.7 mm balloon.If recommended vessel diameter cannot be gained, optimal stent deployment may not be achieved and revised stent sizing should be considered.Based on the reviewed information, no product deficiency was identified.

Manufacturer Narrative

(b)(4).

• 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: 4042894
• MDR Text Key: 4802219
• Report Number: 2024168-2014-05513
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: SE-05-150-120-6F
• Device Lot Number: 02325062
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: SHEATH: 6FR
• Patient Age: 56 YR