MAUDE Adverse Event Report: ABBOTT VASCULAR INC. GRAFTMASTER; CORONARY STENT DELIVERY SYSTEM

Model Number	1012580-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported this was a non-stemi patient with multiple vessel disease, the patient was a high risk for surgery.The diamondback was used for atherectomy in the left anterior descending artery, a perforation occurred.An attempt was made to balloon the perforation but that was unsuccessful.A 2.80x26mm rx graftmaster stent delivery system (sds) was advanced, but it failed to cross the lesion due to the anatomy.The stent was not implanted, the perforation was not sealed.The patient died within minutes on (b)(6) 2024.Per the physician, the perforation was caused by the diamondback.The graftmaster did not cause or contribute to the patient death.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar complaints from this lot.Medical affairs reviewed the reported information.The reviewer concluded that based on the information provided, it can be definitively stated that this patient¿s death was not caused or contributed to by the failure of the graftmaster to cross the lesion, but due to the diamondback orbital atherectomy causing the perforation.The reported patient effect of death, as listed in the graftmaster rx coronary stent graft system, instructions for use ifu, is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.Per the physician, the perforation was caused by the diamondback.The graftmaster did not cause or contribute to the patient death.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure, as it is likely the graftmaster interacted with the heavily calcified lesion during advancement, resulting in the reported failure to advance.Based on the opinion of the physician and medical review, the graftmaster did not cause or contribute to the patient death.Per the physician, the perforation was caused by the diamondback.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.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19617647
• Report Number: 2024168-2024-07656
• Device Sequence Number: 15197201
• Product Code: MAF
• UDI-Device Identifier: 08717648176364
• UDI-Public: (01)08717648176364(17)240831(10)2092841
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 1012580-26
• Device Catalogue Number: 1012580-26
• Device Lot Number: 2092841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 52 KG