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

Catalog Number	1011493-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2018
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.The device was not returned for analysis.The reported difficulties appear to be due to case circumstances.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.The investigation determined that the reported difficulties were due to case circumstances.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 procedure was to treat a lesion in the severely calcified inferior mesenteric artery (ima).The vessel was pre-dilated successfully with a 3.0x40 armada 14 balloon dilatation catheter.The 5.0x18 mm herculink stent system failed to cross the target lesion due to the patient anatomy.When removing the herculink stent system, the stent dislodged from the balloon.A snare device was used, the stent was snared close to the guide catheter and could not be retrieved any further; a cut down had to be performed to successfully retrieve the stent.The procedure was aborted.There patient is stable.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: 7213711
• Report Number: 2024168-2018-00538
• Device Sequence Number: 16393253
• Product Code: NIN
• UDI-Device Identifier: 08717648078026
• UDI-Public: 08717648078026
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/23/2018

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: 1011493-18
• Device Lot Number: 7111361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 01/23/2018
• 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: Required Intervention