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

Catalog Number 1012534-40

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

Patient Problem No Code Available (3191)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling.

Event Description

It was reported that the procedure was to treat a 60% stenosed lesion in the superficial femoral artery (sfa).Pre-dilatation was performed with an unspecified balloon dilatation catheter (bdc).The 6.0mmx40mmx135cm absolute pro vascular self-expanding stent system (sess) was advanced without issue and the stent implant was deployed without issue.During post-dilatation with an unspecified bdc, the stent implant was inadvertently pushed/migrated.Approximately 20mm of the stent implant landed in healthy tissue and 20mm remained in the target lesion.An additional absolute pro vascular stent implant was deployed to treat the portion of the lesion left untreated when the stent implant migrated.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure.There was no additional information provided.

• 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 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: 5079618
• MDR Text Key: 25877581
• Report Number: 2024168-2015-05369
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/15/2015

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: 12/31/2017
• Device Catalogue Number: 1012534-40
• Device Lot Number: 5011561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2015
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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