MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Catalog Number 1012818-19

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Angina (1710); Thrombosis/Thrombus (4440)

Event Date 06/15/2023

Event Type  Injury  

Event Description

It was reported that the procedure was performed on (b)(6) 2023 to treat a lesion in the left anterior descending (lad) coronary artery with mild calcification and mild tortuosity.The 3.0x38mm xience alpine stent delivery system (sds) was implanted; however, during post procedure review, a perforation was noted in the mid stent area; therefore, a 3.5x19mm graftmaster was implanted.On (b)(6) 2023, the patient developed chest pain and an angiography was performed, in which it was noted that the lad stented area had thrombosis due to the graftmaster.The lesion was pre-dilated with a 3.5x12mm nc trek balloon dilatation catheter (bdc) and a 2.75x18mm xience alpine sds was implanted from the mid lad to distal lad.The patient was hospitalized two days after the procedure; however, there was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier: use after expiration the additional xience alpine device referenced in b5 is filed under separate medwatch report number.

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 similar incidents from this lot.It was reported that the graftmaster was used past the expiration date.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use (ifu) states: note the product use by date specified on the package.The expiration date of the product is important for sterility, efficacy, and performance of the device.It is likely the ifu deviation contributed to the reported event.The investigation determined the reported improper or incorrect procedure or method (device expiration issue) appears to be related to the use error.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effects of angina and thrombosis, as listed in the graftmaster rx coronary stent graft system ifu are known patient effects that may be associated with use of a coronary stent in native coronary arteries.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previously filed report, it was determined that the device was used after the expiration date.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 17311362
• MDR Text Key: 319010646
• Report Number: 2024168-2023-07435
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: H000001
• 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
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1012818-19
• Device Lot Number: 8062141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male