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

Catalog Number 1012538-40

Device Problems Break (1069); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, the 10.0x40mmx135cm absolute pro stent was successfully deployed in the left brachial artery.During regular angiographic check-up on (b)(6) 2014, restenosis was noted in older unspecified stents that were distal to the deployed absolute pro stent.However, angiography showed that the absolute pro stent was patent, intact, and well apposed to the vessel wall.After crossing the deployed absolute pro stent with the non-abbott guide wire, the stent was noted to be stretched and possibly fractured.Reportedly, resistance was not noted during advancement of the guide wire through the stent.A 10.0x60mmx135cm absolute pro stent was deployed inside the damaged stent, before successfully completing the procedure to treat the restenosed stents.There were no reported adverse patient sequela and no reported clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the reviewed information, no product deficiency was identified; therefore no corrective action is required.

• 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: 3839505
• MDR Text Key: 4411910
• Report Number: 2024168-2014-03400
• 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: 05/05/2014

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 Catalogue Number: 1012538-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: GUIDE WIRE: BOSTON GLIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 50