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

Catalog Number	1011492-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspection was performed on the returned stent.The failure to advance and dislodgment was not confirmed as the delivery system was not returned.The reported difficulties appear to be due to operational context.It should be noted that rx herculink elite renal and biliary stent system instructions for use states: take care to avoid unnecessary handling.Special care must be taken not to handle or in any way disrupt the stent on the balloon.Although it was reported that the herculink elite stent was inadvertently manipulated by an inexperienced technician during device preparation, it could not be determined if manipulation of the stent during preparation or anatomical conditions contributed to the reported difficulties.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 revealed no other incidents.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 herculink elite stent was inadvertently manipulated by an inexperienced technician during device preparation.The herculink elite stent delivery system (sds) was able to reach the heavily calcified renal artery, but the stent dislodged when trying to cross the lesion.The stent remained on the guide wire and was able to be retracted into the sheath and all devices were removed as a unit.When the sds was outside the anatomy, it was noted that the stent was at the access site.A cutdown was performed at the access site and the stent was successfully removed.The procedure was completed.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6548888
• Report Number: 2024168-2017-03968
• Device Sequence Number: 627466
• Product Code: NIN
• UDI-Device Identifier: 08717648077982
• UDI-Public: (01)08717648077982(17)190131(10)6021561
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/05/2017

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: 01/31/2019
• Device Catalogue Number: 1011492-15
• Device Lot Number: 6021561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/05/2017
• 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
• Patient Age: 75 YR
• Patient Weight: 76