MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number 1012580-16

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Occlusion (1984)

Event Date 03/16/2014

Event Type  Injury  

Event Description

Subsequent to the previously filed medwatch, new information received as follows: there were no attempts made to retrieve or treat the migrated stent.

Event Description

It was reported that the 2.8x19 mm graftmaster stent was used to seal a perforated ostium/diagonal artery, that occurred during use of another device in the proximal to mid left anterior descending (lad) artery.The patient presented to the emergency room suffering from a myocardial infarction and underwent percutaneous coronary intervention of the diagonal.The patient was transferred to the intensive care unit.Post-procedure the patient experienced angina and was transferred back to the cath lab where it was observed that a perforation had occurred during the procedure.The 2.8x19 mm graftmaster stent was deployed at the ostium.Further observation noted that the graftmaster did not seal the perforation and required the placement of an additional 2.8x16 mm graftmaster stent to purposefully jail the diagonal due to the location of the perforation at the ostium, and to seal the remaining perforation, which was completed successfully.No additional information was provided.Additional information received via user facility medwatch report as follows: after deploying the 2.8x16 mm graftmaster stent in the ostium of the diagonal branch, the stent did not adhere to the wall of the artery which allowed the stent to migrate in the lad causing an occlusion.Another stent was deployed and the diagonal was occluded.

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The 2.8x19 mm graftmaster referenced is being filed under a separate medwatch report.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances or exceptions for the lot.A query of the electronic complaint handling database revealed no other incidents for stent migration reported from this lot.Based on the information reviewed, there is no evidence to indicate the presence of a product deficiency.It should be noted that occlusion is listed in the coronary stent graft system, graftmaster rapid exchange (rx) instructions for use (ifu) in the as an adverse event that may be associated with the use of the graftmaster rx coronary stent graft in native coronary arteries.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3840712
• MDR Text Key: 4511889
• Report Number: 2024168-2014-03455
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 1012580-16
• Device Lot Number: 3041141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: STENT: 2.8X19 MM GRAFTMASTER
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 49