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

Catalog Number 1011487-12

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The dislodged stent was confirmed.The failure to advance and resistance was unable to be replicated due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported revealed no other incidents.The investigation determined that the reported difficulties and subsequent patient effects were due to case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that this was a percutaneous intervention (pci) treating a small right renal artery lesion.A herculink elite stent delivery system (sds) advanced over an unspecified guidewire though the guide catheter.Once at the guide catheters distal end, resistance was met during advancement.Reportedly, the resistance was due to the guide catheter and anatomy.The device had failed to cross the lesion and it was then noted that the stents proximal end was flared.All was attempted to be removed as a single unit; however, during removal, resistance was met with the guide catheter and the stent dislodged.The dislodged stent traveled to the right common femoral artery, embedded in calcium.The physician decided to wait for the future planned right groin endarterectomy to surgically remove the dislodged stent.There was no additional information provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previous medwatch report, the additional information was received: following the planned femoral-popliteal bypass surgery, the stent remains in the right common femoral.The stent was not surgically removed.Per surgeon, the stent posed no patient risk.

• 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: 6156350
• MDR Text Key: 61850930
• Report Number: 2024168-2016-08702
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648077821
• UDI-Public: (01)08717648077821(17)181031(10)5111361
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1011487-12
• Device Lot Number: 5111361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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): Other
• Patient Age: 74 YR
• Patient Weight: 97