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

Model Number 9554

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: promus premier ous mr 38 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts in the most proximal strut row were lifted and pulled distally.The undamaged stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues.

Event Description

Reportable based on device analysis completed on 02-oct-2020.It was reported that crossing difficulties were encountered.Vascular access was obtained via the right artery.The 70% stenosed, 3mm x 34mm, concentric, de novo target lesion containing <= 45 degrees bend was located in the moderately tortuous and moderately calcified left anterior descending artery.Pre-dilatation was performed with a 2.5mmx18mm balloon catheter resulting to 55% residual stenosis and a 38 x 3.00 promus premier drug-eluting stent was advanced but failed to cross the lesion.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed stent damage.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10726368
• MDR Text Key: 212718569
• Report Number: 2134265-2020-14678
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: VM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2021
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0024512080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 56