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

Model Number 9550

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: promus premier ous mr 20 x 4.00 stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent identified stent damage.Stent struts in the proximal region of the stent lifted and pulled distally.The 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 multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found no issues with the tip.No other device issues noted.

Event Description

Reportable based on device analysis completed on 14-jan-2021 it was reported that device damage occurred.A 20 x 4.00mm promus premier drug eluting stent was selected for use.However, it was noted that the material was defective.No patient complications were reported.However, returned device analysis revealed stent damaged.

• 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: 11274242
• MDR Text Key: 230108407
• Report Number: 2134265-2021-00545
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0021668965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• 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