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

Catalog Number 1011528-18

Device Problems Difficult To Position (1467); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for evaluation and the reported resistance was unable to be confirmed due to the condition of the returned device.The stent implant was not returned.Based on visual analysis, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the reported resistance and partial stent dislodgment appear to be related to case circumstances.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the renal artery.The 5.0 x 18 mm herculink stent delivery system (sds) was advanced, but was not tracking through the 6f sheath.The sds was removed and attempted again, but during advancement, met resistance half way through the sheath.The sds was replaced with a non-abbott sds, and the procedure was completed successfully.There was no resistance felt during withdrawal of herculik sds.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis found that the stent was dislodged from the sds.Further information from the account reported that after removal, a small portion of the stent was deployed [partially dislodged].During packaging for return, the stent was removed from the sds and discarded.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: RENAL 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: 5131636
• MDR Text Key: 27941550
• Report Number: 2024168-2015-05887
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 1011528-18
• Device Lot Number: 2080861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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