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

Model Number H7493952828350

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that stent damage occurred.A 3.50x28mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, upon unpacking, the middle part of the stent appeared buckled.The device was never used inside the patient.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: fg promus premier us mr 3.50x28mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Proximal and central struts were damaged; struts were lifted, stretched and pulled in distal direction.The undamaged distal section of the crimped stent od (outer diameter) was within maximum crimped stent profile measurement.The balloon cones were 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 kinks along its length.A visual and tactile examination of the shaft polymer extrusion revealed a mid-shaft kink on the proximal side of the port exchange site.A visual and microscopic examination of the tip revealed no issues.No other issues were identified during analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that stent damage occurred.A 3.50x28mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, upon unpacking, the middle part of the stent appeared buckled.The device was never used inside the patient.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7059771
• MDR Text Key: 93334562
• Report Number: 2134265-2017-11623
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844921
• UDI-Public: 08714729844921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2017
• Device Model Number: H7493952828350
• Device Catalogue Number: 39528-2835
• Device Lot Number: 0019198700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2016
• 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