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

Catalog Number S-55-100-120-P6

Device Problems Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion located in the moderately tortuous, mildly calcified, chronic totally occluded, proximal left superficial femoral artery.Laser atherectomy was performed prior to stenting.The supera stent system was advanced, and confirmed to release successfully.The stent was deployed; however, upon removal of the interventional sheath and during closure with a closure balloon, the supera stent became explanted.It was stated that it was possible the incorrect diameter of stent was selected for use; however, this was not confirmed.Although the stent was confirmed on angiography to be deployed successfully this may have contributed to the stent being explanted during use of a closure balloon in the access site.Another supera stent was able to be deployed successfully to complete the case.No adverse patient effects or clinically significant delay in the procedure was reported.No additional information was provided.

Manufacturer Narrative

(b)(4) - failure to follow steps/instructions.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: only the stent was returned thereby confirming that the stent had been explanted.Based on visual analysis of the returned stent, there is no indication of a product deficiency.A review of the job traveler revealed no non-conformances that would have contributed to the reported event.A review of the historical data and a similar incident query for the reported lot was performed and revealed no other incidents reported for this lot.Based on the reviewed information, no product deficiency was identified.Per the supera instruction for use (ifu), the recommended pre-dilatation diameter for a 5.5 mm stent is greater than 5.5 mm balloon.Based on the reported information, it is likely that inadequate pre-dilatation of the lesion site resulted in the stent partially deploying in the interventional sheath and upon removal of the sheath, the stent was explanted.

Manufacturer Narrative

(b)(4).A cine of the procedure was returned and reviewed by an abbott clinical specialist.The reviewer concluded: reportedly, the pre-dilatation balloon was a 5.0 mm balloon, which is smaller than what is recommended in the instructions for use (ifu).The ifu recommends a pre-dilation of 5.5 mm for the 5.5 mm stent.Under pre-dilation of the vessel can negatively impact the overall deployed length of the stent.In this case the vessel was under-dilated by 0.5 mm with the interventional sheath being located close to the proximal end of the stent.It is likely that the stent, which the customer states was deployed had actually partially deployed within the interventional sheath.Post deployment, when the interventional sheath was being removed, the deployed stent was repositioned and relocated within the anatomy to the access site where it was discovered and removed.However, without clear imaging, it cannot be confirmed that the proximal edge of the stent was in fact fully deployed within the vessel.

• 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 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: 4485240
• MDR Text Key: 5335424
• Report Number: 2024168-2015-00607
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: S-55-100-120-P6
• Device Lot Number: 02201060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: GUIDE WIRE: SUPRA CORE, SHEATH: 7F TERUMO
• Patient Age: 78 YR
• Patient Weight: 91