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

Catalog Number S-45-040-120-P6

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the procedure was to treat an 80% stenosed lesion distal to a previously deployed supera stent in the superficial femoral artery (sfa).Pre-dilatation was performed with a 5.0x40mm unspecified balloon dilatation catheter (bdc) for two minutes.The 4.5mmx40mmx120cm supera self-expanding stent system (sess) was successfully advanced to the target lesion and the stent was deployed.However, during withdrawal of the delivery catheter, resistance was met and the tip separated.When the delivery catheter was removed, it was noted that the stent elongated and was explanted from the patient's anatomy.The separated tip was successfully retrieved using a snare device.Due to the clinically significant delay in the procedure, the decision was made to stop the procedure at that time.Future treatment of the vessel is planned; however, an exact date for the planned treatment is not known.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.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 electronic complaint handling database revealed no other incidents reported from this lot.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: 4048035
• MDR Text Key: 12575502
• Report Number: 2024168-2014-05575
• 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
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: S-45-040-120-P6
• Device Lot Number: 02215051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention