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

Catalog Number	1011487-12
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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
• Common Device Name: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6156350
• Report Number: 2024168-2016-08702
• Device Sequence Number: 16254275
• Product Code: NIN
• UDI-Device Identifier: 08717648077821
• UDI-Public: (01)08717648077821(17)181031(10)5111361
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2016

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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Weight: 97