Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9552
Device Problems Component Missing (2306); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2023
Event Type  malfunction  
Manufacturer Narrative
E1 initial reporter phone: (b)(6).
 
Event Description
It was reported that the stent dislodgement occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified mid left anterior descending (lad).A 28mm x 4.00mm promus premier drug-eluting stent was selected for treatment.Upon opening of the package, the device was found that the stent had dislodged and there was no balloon attached.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition was stable following the procedure.
 
Manufacturer Narrative
E1 initial reporter phone: (b)(6).Device evaluated by mfr.Promus premier ous mr 28 x 4.00mm stent delivery system catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Visual inspection revealed that the device was received with the stent detached from the balloon.The first 3 rows on both the proximal and distal ends of the stent did not appear damaged.However, the remainder of the stent found that the stent was stretched with stent struts misaligned.A visual examination of the balloon material could not identify that the balloon had been inflated.There was clear evidence of stent crimp on the balloon material.No issues were identified with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.The bumper tip showed no signs of distal tip damage.Microscopic analysis of the detached crimped stent found that the first 3 rows on both the proximal and distal ends of the stent did not appear damaged.However, the remainder of the stent found that the stent was stretched with stent struts misaligned.It is not clear from the damage to the stent if the stent had been deployed or simply pulled off the balloon.A microscopic examination of the balloon identified no damages.There was no inflation media present inside the balloon.
 
Event Description
It was reported that the stent dislodgement occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified mid left anterior descending (lad).A 28mm x 4.00mm promus premier drug-eluting stent was selected for treatment.Upon opening of the package, the device was found that the stent had dislodged and there was no balloon attached.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition was stable following the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17936466
MDR Text Key325702478
Report Number2124215-2023-51730
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9552
Device Catalogue Number9552
Device Lot Number0030680609
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age75 YR
Patient SexFemale
Patient Weight48 KG
-
-