MAUDE Adverse Event Report: ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL

Catalog Number 1011528-15

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the heavily calcified, mildly tortuous right renal artery.A 5x15mm herculink elite stent delivery system (sds) was being used with a non-abbott sheath.The sds failed to cross due to the anatomy.During removal, the stent dislodged from the balloon and remained on an unspecified wire.A 2.5x20mm trek balloon was used to retrieve the stent into the sheath, and all devices were removed together.An unspecified herculink stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 complaints reported from this lot.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.The difficulty encountered during advancement was likely due to interaction with the anatomy.Additionally, it is likely that during the attempt to cross the lesion, this caused the stent to become compromised on the balloon resulting in dislodgement and unexpected medical intervention to retrieve the stent with a snare.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12071020
• MDR Text Key: 258683154
• Report Number: 2024168-2021-05439
• 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
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 1011528-15
• Device Lot Number: 9092461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5FR 45CM COOK SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR