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

Catalog Number 1011504-18

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.Date of event: date of event has been estimated.Date of implant: date of implant has been estimated.(b)(4).

Event Description

User facility medwatch report received that states: stent placed in celiac artery in mesentery.Stent deployed without issue.Balloon malfunction [separation] on removal prolonging time of procedure.Balloon was able to retrieved.No additional information was received.

Manufacturer Narrative

Internal file number - (b)(4).Date of event correction: date of occurrence.Implant date correction: date of implant.It was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.The device was not returned for analysis.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 of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial report, additional information was received.The balloon became separated inside the anatomy.No additional information was received.

• Brand Name: RX HERCULINK ELITE RENAL STENT SYSTEM
• Type of Device: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8667115
• MDR Text Key: 146940937
• Report Number: 2024168-2019-04357
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1011504-18
• Device Lot Number: 6080561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR