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

Model Number H7493952824300

Device Problems Material Perforation (2205); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that shaft perforation occurred.After a guide wire crossed the lesion, a 3.00x24mm promus premier¿ drug-eluting stent (des) was advanced to treat the lesion.The guide wire was inserted at the distal end of the stent.However, it was noted that the guide wire exited distal to the proximal wire lumen port and that the physician perforated the wire lumen of the stent with the guide wire being used.The stent was removed with no patient harm.A new 3.00x24mm promus premier¿ des was used on the same wire and the procedure was completed.No patient complications were reported and the patient was discharged the following day with great prognosis.

Manufacturer Narrative

Device evaluated by mfr.: promus premier mr us 3.00 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od(outer diameter) was measured and the result was within the maximum crimped stent profile measurement.The bumper tip of the device was examined and damage was noted.The tip was stretched.The balloon cones were reviewed and there were no issues to note.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found that the hypotube revealed multiple kinks.A visual and tactile examination of the shaft polymer extrusion identified midshaft kinks at 115mm and 125mm distal from the hypotube/ midshaft bond.The inner/outer shaft polymer extrusion was examined and there were no signs of damage.The bi-component bond showed no signs of damage or strain.The device was loaded over a 0.014¿ guidewire without issue.No other issues were identified during the product analysis.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that shaft perforation occurred.After a guide wire crossed the lesion, a 3.00x24mm promus premier¿ drug-eluting stent (des) was advanced to treat the lesion.The guide wire was inserted at the distal end of the stent.However, it was noted that the guide wire exited distal to the proximal wire lumen port and that the physician perforated the wire lumen of the stent with the guide wire being used.The stent was removed with no patient harm.A new 3.00x24mm promus premier¿ des was used on the same wire and the procedure was completed.No patient complications were reported and the patient was discharged the following day with great prognosis.

• 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: 7110234
• MDR Text Key: 94653477
• Report Number: 2134265-2017-12089
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844853
• UDI-Public: 08714729844853
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2018
• Device Model Number: H7493952824300
• Device Catalogue Number: 39528-2430
• Device Lot Number: 0019802575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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