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

Catalog Number	1011498-18
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	03/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.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 did not reveal a lot specific product issue.The rx herculink elite renal and biliary stent system instructions for use state that the system is indicated for use in patients with atherosclerotic disease of the renal arteries or restenotic atherosclerotic lesion located within 10 mm of the renal ostium.It could not be determined if the off-label use contributed to the reported difficulties.It is likely that dislodgment occurred due to interaction with the heavily calcified anatomy.The investigation determined the reported difficulties appear to be related to operational context of the procedure and 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 the patient underwent a procedure to treat severe stenosis in the proximal superior mesenteric artery (sma) and severe iliac stenosis.A 6 french guide catheter was advanced and the 6.0 x 18 mm herculink stent delivery system was advanced; however, the stent dislodged from the delivery catheter when attempting to cross into the superior mesenteric artery.The dislodged stent was able to be pulled into the right mid common iliac artery using a snare device.An omnilink stent was then deployed in the right mid common iliac artery to crush the stent to the vessel wall.Post stenting angiography noted the stent widely patent.The procedure continued with implantation of a 6.0 x 18 mm herculink stent in the sma and implantation of an 8.0 x 29 mm omnilink stent in the left iliac artery.Post stenting angiography noted the stents widely patent.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6440825
• Report Number: 2024168-2017-02615
• Device Sequence Number: 1042040
• Product Code: NIN
• UDI-Device Identifier: 08717648078170
• UDI-Public: (01)08717648078170(17)180731(10)5081361
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 03/28/2017

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: 07/31/2018
• Device Catalogue Number: 1011498-18
• Device Lot Number: 5081361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATH: 6 FRENCH IM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 52