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

Model Number 9550

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Patient is over 18 years old.

Event Description

It was reported that stent fracture post-deployment occurred.Vascular access was obtained via the femoral artery.The 18x3.50mm, concentric, de novo target lesion was located in the non-tortuous and mildly calcified unprotected left main coronary artery.During implanting of a 20 x 3.50 promus premier drug-eluting stent, the middle part of the stent was fractured.Another stent was deployed to cover the site fracture and complete the procedure.No patient complications nor injuries were reported and the patient's status was stable.

Manufacturer Narrative

Device is a combination product.Patient is over 18 years old.A promus premier ous mr 20 x 3.50 mm stent delivery system was returned for analysis without the stent.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture is within max crimped stent profile measurement.The balloon cones were reviewed and found to be in a deflated state.Signs of positive pressure were noted to be applied to the cones as its wings were relaxed and not folded.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along several location of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues were identified during the product analysis.

Event Description

It was reported that stent fracture post-deployment occurred.Vascular access was obtained via the femoral artery.The 18x3.50mm, concentric, de novo target lesion was located in the non-tortuous and mildly calcified unprotected left main coronary artery.During implanting of a 20 x 3.50 promus premier drug-eluting stent, the middle part of the stent was fractured.Another stent was deployed to cover the site fracture and complete the procedure.No patient complications nor injuries were reported and the patient's 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: 9939191
• MDR Text Key: 187072101
• Report Number: 2134265-2020-04744
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0023323500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention