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

Catalog Number 1011539-18

Device Problems Material Rupture (1546); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

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 evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a 90% stenosed, narrow, and concentric re-stenosed lesion in the mid renal artery.A 7x18mm rx herculink elite stent system was being used per the instructions for use to treat restenosis; however, during an attempt to inflate the balloon an inability to ramp up and hold pressure in the balloon was observed.The stent partially deployed at the ends, but not completely.The delivery system was removed and an unknown balloon catheter was advanced and used to successfully post-dilate the stent to its full diameter.The case was finished with good results.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual and functional inspections were performed.The reported balloon rupture was unable to be confirmed as the balloon was able to inflate and hold pressure without any ruptures noted.The reported difficulty to deploy was unable to be confirmed as the stent implant was deployed during the procedure.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 identified no other similar incidents from this lot.The investigation was determined the reported difficulty to deploy and balloon rupture appear to be related to circumstances of the procedure.The noted tearing of the guide wire exit notch appears to have resulted from manipulation and/or interaction with the guide wire.This type of mechanical damage can occur if the guide wire and stent delivery device are pull in opposite direction causing the tearing at the guide wire exit notch resulting in the inability to deploy the balloon and stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8609628
• MDR Text Key: 145031912
• Report Number: 2024168-2019-03797
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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: 08/31/2021
• Device Catalogue Number: 1011539-18
• Device Lot Number: 8091361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR