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

Catalog Number S-45-080-120-P6

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2015

Event Type  Injury  

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.

Event Description

It was reported that the procedure was to treat a lesion in the superficial artery (sfa).The vessel was prepped using an unspecified 5x60 mm balloon catheter.A 4.5x80 mm supera self expanding stent system was advanced toward the target lesion.An attempt was made to deploy the stent from the mid to the proximal sfa but the stent did not release from the delivery system.Reportedly the stent was partially deployed, the stent was fully covering the target lesion and was also elongated greater than 10% into another vessel.The stent stretched/elongated to the common femoral artery.It was suspected that the device was pulled back before it was released.Post dilatation was performed using an unspecified 5x60 mm balloon catheter to fully appose the stent to the vessel wall.The procedure was ended.There was no adverse impact to the patient.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned and the deployment difficulty and elongation were not confirmed because the stent was already deployed.Based on a visual inspection of the returned product, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A definitive cause for the reported deployment difficulty could not be determined.The elongation likely occurred due to operational context.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information reviewed, there is no indication the issue was caused by, or related to the design, manufacture or labeling.

• 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: 5230307
• MDR Text Key: 31400498
• Report Number: 2024168-2015-06937
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 5061861
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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