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

Model Number 24623

Device Problem Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: the event date was not provided.The first date of the month of the aware date was used.

Event Description

It was reported that stent fracture that caused foot pain to the patient occurred.The patient presented with claudication.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified tibial artery.After a 0.014 inch guide wire crossed the lesion, a 2.50x38mm promus premier drug-eluting stent was deployed to treat the lesion and was post-dilated.However, post deployment, it was noted that the stent appeared to have a large gap or separation between struts 3 and 4 at the proximal end.The physician used angioplasty a second time and it still looked abnormal.The procedure was completed despite this.Upon follow-up, the patient complained on ongoing foot pain and it was noted that the stent appeared crushed and deformed.Additional balloon angioplasty was performed to rectify the crushed stent and a non-bsc stent was implanted to keep the vessel patent.

Event Description

It was reported that stent fracture that caused foot pain to the patient occurred.The patient presented with claudication.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified tibial artery.After a 0.014 inch guide wire crossed the lesion, a 2.50x38mm promus premier drug-eluting stent was deployed to treat the lesion and was post-dilated.However, post deployment, it was noted that the stent appeared to have a large gap or separation between struts 3 and 4 at the proximal end.The physician used angioplasty a second time and it still looked abnormal.The procedure was completed despite this.Upon follow-up, the patient complained on ongoing foot pain and it was noted that the stent appeared crushed and deformed.Additional balloon angioplasty was performed to rectify the crushed stent and a non-bsc stent was implanted to keep the vessel patent.It was further reported that the target lesion was located in the tibioperoneal trunk.

Manufacturer Narrative

D4 model number: corrected to 24623.D4 catalog number: corrected to 24623.Date of event: the event date was not provided.The first date of the month of the aware date was used.

• 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: 10771697
• MDR Text Key: 214158124
• Report Number: 2134265-2020-14932
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24623
• Device Catalogue Number: 24623
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention