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

Catalog Number	1011499-15
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.Additionally, a review of the complaint history for the reported lot was performed and revealed no similar incidents.The investigation determined that the reported loose stent appears to be related to operational context of the procedure, as it is likely the device interacted with the anatomy causing the stent to become loose.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion distal to the tortuous ostium of the renal artery with no calcification.A 5f non-abbott sheath was placed past the lesion in order to assist with crossing the ostium.A 6.0 x 15 mm rx herculink elite stent delivery system (sds) was advanced through the sheath with no reported resistance.On attempting to withdraw the sheath slightly to allow the stent to be deployed at the lesion, it was noted that the stent appeared loose on the balloon of the sds.In order to prevent the stent dislodging, no further repositioning of the sds was performed and the stent was deployed.The site of the deployment was at the distal end of the lesion leaving a part of the proximal lesion uncovered.A second unspecified stent was successfully deployed to treat the remainder of the lesion and complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8540354
• Report Number: 2024168-2019-03185
• Device Sequence Number: 1743970
• Product Code: NIN
• UDI-Device Identifier: 08717648078194
• UDI-Public: 08717648078194
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 1011499-15
• Device Lot Number: 7031361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 5F COOK