MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM; STENTS, DRAINS AND DIALATORS FOR BILIARY DUCTS

Model Number	REF 1011493-18
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was scheduled for pta of celiac artery an superior mesenteric artery.Dr.(b)(6) stented the celiac and then we moved on the superior mesenteric.Doctor ballooned sma and then proceeded to try and stent the sma.The stent came off of the deployment balloon but remained on the wire.We were able to get the stent back to the sheath and into the tissue tract, however we were unable to get it through the soft tissue tract so dr.(b)(6) asked dr.(b)(6) to do a cut down on the right groin to remove the undeployed stent.Dr.(b)(6) successfully was able to remove the stent and patient was transferred to icu in stable condition.The patient remained awake, alert and stable for the entire procedure and was made aware of the situation and was able to talk to the anesthesiologist and surgeon prior to being put to sleep for surgery.

• Brand Name: ABBOTT RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM
• Common Device Name: STENTS, DRAINS AND DIALATORS FOR BILIARY DUCTS
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA 95054
• MDR Report Key: 8102078
• Report Number: MW5081601
• Device Sequence Number: 2037941
• Product Code: FGE
• UDI-Device Identifier: 08717648078026
• UDI-Public: (01)08717648078026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 01/31/2021
• Device Model Number: REF 1011493-18
• Device Lot Number: 8021361
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2018
• 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: Hospitalization