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

Catalog Number 1011487-12

Device Problems Positioning Failure (1158); Inflation Problem (1310); Off-Label Use (1494); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 an eccentric, de novo lesion in the narrow, mid right vertebral artery with 90% stenosis.A 4.0 x 12 mm herculink elite stent delivery system (sds) was advanced to the lesion.While the sds held pressure, the balloon failed to inflate.The stent was not deployed and the sds was simply removed from the anatomy with no reported issue.The procedure was successfully completed with a new herculink elite sds.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Additional information: returned device analysis identified the stent implant was returned dislodged and the entire length of the stent implant was crushed.It was confirmed that the correct device was returned and the stent dislodgement/ damage did not occur during the procedure.

Manufacturer Narrative

Device codes: 3270 labeled.Internal file number - (b)(4).Correction device code 1158 was removed.Evaluation summary: a visual and functional inspections were performed.The reported inflation issue was unable to be confirmed as the balloon was able to inflate and hold pressure without any issues noted.The reported failure to deploy the stent was unable to be confirmed since the stent implant was returned dislodged off the balloon.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 reported from this lot.It should be noted that per rx herculink elite renal and biliary stent system instructions for use (ifu), the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novo or restenotic atherosclerotic lesion, located within 10 mm of the renal ostium.This violation of the ifu does not appear to have contributed to the failure to deploy or inflation issue.The investigation was unable to determine a conclusive cause for the reported inflation issue and failure to deploy.Based on the follow-up information provided, it is likely that manipulation and/or inadvertent mishandling during packing for return analysis resulted in the noted stent dislodgment, stent damage and kinks to the inner/outer member.There were visible crimp marks on the balloon between the markers suggesting the stent was originally positioned correctly and securely at the time of manufacture.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 8317472
• MDR Text Key: 135725898
• Report Number: 2024168-2019-00944
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1011487-12
• Device Lot Number: 7081461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1