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

Model Number 9550

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent fracture occurred.The 60% stenosed, 14mmx3.5mm target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.Following pre-dilatation with a balloon catheter, a 20 x 3.50 promus premier drug-eluting stent was advanced for treatment.However, upon removal, it was noted that some parts of the stent were missing.The patient was noted to be under observation.No patient complications were reported and the patient's status was noted to be stable.

Manufacturer Narrative

Device is a combination product.Describe event or problem updated.

Event Description

It was reported that stent fracture occurred.The 60% stenosed, 14mmx3.5mm target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.Following pre-dilatation with a balloon catheter, a 20 x 3.50 promus premier drug-eluting stent was advanced for treatment.However, upon removal, it was noted that some parts of the stent were missing.The patient was noted to be under observation.No patient complications were reported and the patient's status was noted to be stable.It was further reported that after the stent was implanted, intravascular ultrasound was performed and the stent was found to have a gap/breach.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: device was not returned for analysis.However, a media was received and reviewed.The review concluded that there was no evidence of any stent structural damage or missing stent material.The images provided identified signs of stent mal-apposition, the images were found to be consistent with a gap between the stent and vessel wall.

Event Description

It was reported that stent fracture occurred.The 60% stenosed, 14mmx3.5mm target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery.Following pre-dilatation with a balloon catheter, a 20 x 3.50 promus premier drug-eluting stent was advanced for treatment.However, upon removal, it was noted that some parts of the stent were missing.The patient was noted to be under observation.No patient complications were reported and the patient's status was noted to be stable.It was further reported that after the stent was implanted, intravascular ultrasound was performed and the stent was found to have a gap/breach.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8404897
• MDR Text Key: 138271342
• Report Number: 2134265-2019-01931
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2020
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0021679168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/13/2019; 04/18/2019
• Supplement Dates FDA Received: 03/28/2019; 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 78