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

Model Number 9548

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 12 x 3.50 promus premier drug-eluting stent was advanced but could not track down lesion and the stent got damaged.The procedure was completed with a different device.There were no patient complications nor injuries reported.

Manufacturer Narrative

Device is a combination product.(b5) describe event or problem updated.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 12 x 3.50 promus premier drug-eluting stent was advanced but could not track down lesion and the stent got damaged.The procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the target lesion had 70% stenosis, located in the mildly tortuous and moderately calcified left anterior descending artery.It was the shaft that was bent during the procedure.The patient status was stable.

• 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: 10399608
• MDR Text Key: 202696603
• Report Number: 2134265-2020-11063
• 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
• Report Date: 09/09/2020

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: 07/22/2020
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0022451988
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 68