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

Catalog Number S-55-100-120-P6

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2014

Event Type  malfunction  

Event Description

It was reported that during the procedure of the non-calcified, non-tortuous, right superficial femoral artery with reference vessel diameter of 6 mm the supera stent delivery system (sds) was being advanced over the unspecified 0.018 guide wire and resistance was met and it felt sticky.During the attempt to pull back and remove the sds from the anatomy the distal tip detached and remained on the guide wire.The detached tip was removed on the guide wire from the anatomy.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).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 resistance with the guide wire could not be confirmed due to the condition of the returned device.The reported tip separation was confirmed.Based on a visual inspection of the returned device, 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 query of the complaint handling database and a review of the historical data revealed no other similar 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: 4045731
• MDR Text Key: 4906545
• Report Number: 2024168-2014-05563
• 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: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• 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: 02215060
• 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: 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 Age: 64 YR
• Patient Weight: 73