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

Catalog Number	1011498-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2016
Type of Reportable Event	Malfunction
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 revealed no other incidents.It was reported the herculink elite was used to treat the subclavian artery.It should be noted the herculink elite stent system instructions for use states: the rx herculink elite biliary stent system is intended for palliation of malignant strictures in the biliary tree.In this case, it does not appear that the off-label use would have caused or contributed to the reported rupture.The investigation determined the reported difficulties appear to be related to operational context of the procedure.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 the procedure was to treat a lesion in the subclavian artery.The 6.0mmx18mmx80cm herculink elite stent delivery system (sds) was advanced without resistance in the patient anatomy.However, the balloon completely failed to inflate.The sds was removed from the patient anatomy, while outside the patient anatomy the sds failed to inflate again.A leak was noted coming from the balloon.A same size herculink sds was used to complete the procedure.There were no adverse patient effects.There was no clinically significant delay in the procedure.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: 6012732
• Report Number: 2024168-2016-06781
• Device Sequence Number: 11003203
• Product Code: FGE
• UDI-Device Identifier: 08717648078170
• UDI-Public: (01)08717648078170(17)181231(10)6011961
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063481
• 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): 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 1011498-18
• Device Lot Number: 6011961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2016
• Initial Report FDA Received Date: 10/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1