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

Model Number H7493952824220

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

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.During unpacking of a 2.25x24mm promus premier¿ drug-eluting stent, it was noted that a stent strut was pulled up.The device never entered the patient's body and the procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the stent delivery system was returned for analysis.A visual examination of the stent found that the first proximal stent row was damaged with stent struts lifted.The undamaged crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.A visual and microscopic examination of the tip found no damage.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 device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the device found no issues along the mid shaft, inner or outer shaft polymer extrusion.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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.During unpacking of a 2.25x24mm promus premier¿ drug-eluting stent, it was noted that a stent strut was pulled up.The device never entered the patient's body and 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
• MDR Report Key: 7623307
• MDR Text Key: 111905869
• Report Number: 2134265-2018-05510
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844822
• UDI-Public: 08714729844822
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: H7493952824220
• Device Catalogue Number: 39528-2422
• Device Lot Number: 21644719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1