MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Model Number 9550

Device Problem Device Damaged by Another Device (2915)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that the stent damaged, obstruction occurred and required additional intervention.The 80% stenosed target lesion was located in the moderately tortuous and non-calcified left main (lm) and left anterior descending artery (lad).A 2.50 x 23 mm non-boston scientific stent was implanted into the distal end of the blood vessel, and then, a 3.00 x 20 mm promus premier stent was overlapped about 10mm in the non-boston scientific stent.The physician was preparing to retract the promus premier stent towards the proximal end of the blood vessel.However, it become stuck with in a non-boston scientific stent.It was noted that the physician thought the stent had a rough edge.There was concern that forcefully pulling the promus premier stent out could lead to patient complications.On angiography, it was noted a "smoke" was seen, and blood flow was found to be blocked, causing risk of ischemia.The stent did not completely cover the lesion, and another stent was implanted.The patient did not complain of discomfort during the procedure.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18615783
• MDR Text Key: 334222235
• Report Number: 2124215-2024-03561
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0031705992
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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
• Treatment: MICROPORT STENT - MICROPORT SCIENTIFIC CORPORATION
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR