MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012534-20

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a mildly calcified lesion in the left common iliac artery.The 6.0mmx20mmx135cm absolute pro self-expanding stent system (sds) was successfully advanced to the target lesion and the stent was deployed without issue.During advancement of the 5.0mmx250mmx135cm armada 35 balloon dilatation catheter (bdc) for post-dilatation, although no resistance was met, the bdc pushed the deployed absolute pro stent causing it to migrate into healthy tissue.Another absolute pro stent was deployed to treat the remainder of the lesion left untreated when the first stent migrated.The procedure was successfully completed at that time, with no reported adverse patient sequela and no 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 lot history record revealed no non-conformances.A query of the complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.The 5.0mmx250mmx135cm armada referenced, is being filed under a separate manufacturing report number.

• Brand Name: ABSOLUTE PRO VASCULAR 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4169800
• MDR Text Key: 18796585
• Report Number: 2024168-2014-06676
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• 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
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1012534-20
• Device Lot Number: 2120461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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: DILATATION CATHETER: 5.0MMX250MMX135CM ARMADA 35
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 70