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

Model Number 1011487-18

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).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 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.

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 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.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: HERCULINK ELITE BILIARY
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9151293
• MDR Text Key: 162635961
• Report Number: 2024168-2019-12325
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648077845
• UDI-Public: 08717648077845
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 68 YR