MAUDE Adverse Event Report: ABBOTT VASCULAR HERCULINK ELITE BILIARY; STENT, RENAL

Model Number	1011487-18
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
User facility medwatch report received that states: [the stent (herculink 4.0x18) was advanced to the renal artery and came off the balloon.The balloon delivery and wire was removed.Microsnare inserted but unable to retrieve stent.Stent noted to be in iliac artery.Renal area of concern was stented and due to blood thinners the sheath was sutured in place.Transferred to preop where retained renal stent was removed in the or.What was the original intended procedure? renal stent placement.] no additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Device evaluated by mfr: correction: device status changed from returning to discarded.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.Based on the information provided, a definitive cause for the stent dislodgement could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
User facility medwatch report received that states: [the stent (herculink 4.0x18) was advanced to the renal artery and came off the balloon.The balloon delivery and wire was removed.Microsnare inserted but unable to retrieve stent.Stent noted to be in iliac artery.Renal area of concern was stented and due to blood thinners the sheath was sutured in place.Transferred to preop where retained renal stent was removed in the or.What was the original intended procedure? renal stent placement.] additional information was received from the account confirming that the stent implant was not removed and remains in the anatomy.No additional information was provided.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: HERCULINK ELITE BILIARY
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9151293
• Report Number: 2024168-2019-12325
• Device Sequence Number: 3221413
• Product Code: NIN
• UDI-Device Identifier: 08717648077845
• UDI-Public: 08717648077845
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2020

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: 08/31/2021
• Device Model Number: 1011487-18
• Device Catalogue Number: 1011487-18
• Device Lot Number: 8091761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 07/20/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/11/2019; 07/20/2020
• 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; Required Intervention; Disability
• Patient Age: 68 YR