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

Catalog Number	1011493-15
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
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.(b)(4).Evaluation summary: visual inspection was performed on the returned device.The dislodged stent was confirmed.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.The investigation determined that the reported dislodgment was likely due to operational context (inadvertent mishandling).The rx herculink elite instruction for use, instructs: prior to using the rx herculink elite peripheral stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Failing to inspect the stent prior to use did not cause the dislodgment.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 5.0x15mm rx herculink elite stent delivery system (sds) was advanced to the target lesion and the balloon inflated when the stent was noted to be missing.The stent was found inside the protective sheath.The sds was removed and the procedure completed with another device.There was no clinically significant delay in the procedure and no adverse patient effects.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: 8560852
• Report Number: 2024168-2019-03368
• Device Sequence Number: 13862699
• Product Code: NIN
• UDI-Device Identifier: 08717648078019
• UDI-Public: 08717648078019
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 02/28/2022
• Device Catalogue Number: 1011493-15
• Device Lot Number: 9032261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1