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

Catalog Number S-07-040-120-6F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a significantly calcified lesion in the iliac artery.Pre-dilatation was performed using an unspecified balloon dilatation catheter (bdc).After the 7.0x40mmx120cm stent was deployed, resistance was met during withdrawal of the delivery catheter, and the tip of the delivery catheter separated.The separated tip was successfully retrieved from the patient's anatomy using a snare.However, the deployed stent was slightly damaged by the snare device.The decision was not to treat the damage stent as the damage was minor.There were no reported adverse patient sequela; however, there was a reported clinically significant delay in the procedure.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 the 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.

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: 3781070
• MDR Text Key: 4442490
• Report Number: 2024168-2014-02699
• 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: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: S-07-040-120-6F
• Device Lot Number: 02110573
• 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: 06/01/2013
• 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