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

Catalog Number 1012817-19C

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional graftmaster device referenced in b5 is filed under separate medwatch report number.

Event Description

It was reported that the procedure was to treat a perforation in the left circumflex (lcx) artery with heavy calcification and heavy tortuosity.The 2.8x19mm graftmaster covered stent system was attempted to be advanced to the target lesion; however, failed to cross due to the anatomy and the stent became bent.Therefore, the graftmaster was removed from the anatomy and another 2.8x19mm graftmaster stent was attempted to cross the target lesion; however the 2nd graftmaster also failed to cross due to the anatomy.There was no adverse patient sequela.The procedure was completed with another device.No additional information was provided.

Event Description

Subsequent to the initial report being filed it was reported that the account was aware that the stent had become dislodged and the shaft had separated on the graftmaster device.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material deformation, stent dislodgement and shaft separation were confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.The lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties 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.

• 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: 18751523
• MDR Text Key: 335931690
• Report Number: 2024168-2024-02173
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012817-19C
• Device Lot Number: 3011641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Male