MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ACCULINK; STENT, CAROTID

Model Number	1011343-40
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the internal carotid artery with heavy calcification, heavy tortuosity and 95% stenosis.The acculink self expanding stent system (sess) was advanced to the lesion and deployment was attempted; however, the handle was broken and the stent completely failed to deploy.Another acculink sess was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that the shaft was broken.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and the reported break handle was able to be confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during deployment interaction with the heavily calcified, heavily tortuous and 95% stenosed anatomy prevented the shaft lumens from moving freely thus resulting in the reported/noted activation failure.Manipulation of the compromised device in attempts to deploy the stent resulted in the noted sheath kink and ultimately resulted in the reported handle break/noted shaft separation/bunched contributing to the reported activation failure.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACCULINK
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20735407
• Report Number: 2024168-2024-13727
• Device Sequence Number: 18296139
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: (01)08717648076374(17)251130(10)3121961
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 3121961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.014INCH AND ASAHI CHIKAI GUIDE WIRES.
• Patient Sex: Unknown