MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM

Catalog Number 1011499-15

Device Problems Difficult To Position (1467); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

It was reported that when advancing the 6.0x15 mm herculink stent delivery system through the tuohy, it felt tight and resulted in dislodgement of the stent implant inside the tuohy.The same tuohy was used with another herculink stent successfully without further issue.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and the reported dislodgment was confirmed.The resistance with the rotating hemostatic valve was not tested as the stent had already been dislodged from the balloon.Based on visual analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other incidents for difficult to position or dislodgment reported for this lot.Based on the information reviewed, there is no indication of a product deficiency.

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: 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: 3672897
• MDR Text Key: 4241819
• Report Number: 2024168-2014-01436
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• 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: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• 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: 1011499-15
• Device Lot Number: 2121361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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