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

Catalog Number	1011490-15
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspection was performed on the returned unit.The reported dislodgment was confirmed.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 lot revealed no other incidents.It should be noted that the indication for use listed in the rx herculink elite instruction for use (ifu) states: the device is intended to open lumen restrictions in the biliary tree, renal arteries and protected peripheral arteries.It is likely that the stent dislodgment was due to anatomical conditions.The investigation determined the reported difficulties were due to operational context.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 during a procedure of the narrow, mildly calcified, ostium of the vertebral artery, the 4.5 x 15 mm herculink elite stent delivery system (sds) was advanced to the target lesion; however, the stent dislodged from the balloon and migrated to the distal end of the brachial artery.The sds was removed.Angiography showed good blood flow, so no attempt was made to retrieve the dislodged stent.There was no additional information provided.

• 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: 7585054
• Report Number: 2024168-2018-04350
• Device Sequence Number: 10795731
• Product Code: NIN
• UDI-Device Identifier: 08717648077920
• UDI-Public: 08717648077920
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: 10/31/2020
• Device Catalogue Number: 1011490-15
• Device Lot Number: 7111461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/08/2018
• 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