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

Catalog Number 1011528-18

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

Patient id: (b)(6).It was reported that during the procedure on (b)(6) 2024, the 5.0x18 mm rx herculink elite stent failed to cross through stenosis of the renal artery.When attempting to withdraw the stent through the 6f guiding sheath, resistance was felt.The herculink stent dislodged from the balloon into the aorta.Attempts to snare the stent were unsuccessful.Since the stent could not be snared it was embedded in a peripheral branch from the hypogastric artery.A new 5.0x18 mm rx herculink elite stent was implanted to complete the procedure.The device deficiency and adverse event are related to the index procedure.There were no adverse patient sequelae and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 incidents.The investigation determined the reported difficulties and subsequent device embedded in tissue or plaque in addition to unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.Na.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.The reported difficult to remove could not be tested due to the condition of the returned device.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 incidents.The investigation determined the reported difficulties and subsequent device embedded in tissue or plaque in addition to unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to circumstances of the procedure.In this case, it is likely the device interacted with the 95% stenosed lesion during advancement, causing the reported failure to advance.Further interaction with the guiding sheath during retraction of the device, as resistance was noted, likely contributed to the reported difficult to remove; ultimately causing the reported stent dislodgement.Attempts to snare the stent were unsuccessful.Since the stent could not be snared it was embedded in a peripheral branch from the hypogastric artery.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.D9, h3: device returning update from no to yes.H6: removed component code 4755.H6: removed type of investigation code 4117.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18609114
• MDR Text Key: 334117023
• Report Number: 2024168-2024-01221
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011528-18
• Device Lot Number: 3090761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F HALO ONE SHEATH; SPARTACORE GUIDEWIRE 0.014
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG