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

Catalog Number	1011493-12
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The product was not returned to abbott vascular for analysis.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 identified no other similar incidents reported from this lot.The investigation determined the reported physical resistance and stent dislodgment appear to be related to circumstances of the procedure.Based on the reported information, it is likely that during advancement, the stent delivery system (sds) encountered resistance with the 99% stenosed and calcified anatomy resulting in the reported resistance ultimately dislodging the stent from the balloon.There is no indication of a product quality issue with respect to manufacture, design or labeling.User facility medwatch report number mw5083242.[sus voluntary event report #mw5083242 (b)(4)].
Event or Problem Description
User facility medwatch report number mw5083242 received stating the following: during procedure, patient needed a stent to their inferior mesenteric artery.While trying to place a stent, the stent came off the balloon catheter and had to be retrieved with a snare.Retrieval of stent was successful, and stent was removed from the body successfully.Additionally, it was reported that the lesion was 99% stenosed, with calcification at the ostium of the vessel.Resistance was met during advancement to the lesion.When the stent system reached the lesion, the stent dislodged.A different stent was implanted to complete the procedure and the patient was transported back to room in stable condition.There was no reported adverse patient sequela or a clinically significant delay.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: 8383782
• Report Number: 2024168-2019-01609
• Device Sequence Number: 11260296
• Product Code: NIN
• UDI-Device Identifier: 08717648078002
• UDI-Public: 08717648078002
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1011493-12
• Device Lot Number: 8020661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/01/2019
• 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: 80 YR