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

Model Number H7493925120300

Device Problems Bent (1059); Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that stent damage and foreign matter occurred.The target lesion was located in the mildly tortuous left circumflex artery (lcx).A non-bsc stent was implanted in the ostial left anterior descending artery (lad) for more than 10 years ago and it was noted that the edge of the device was slightly deployed in left main trunk (lmt).Pre-dilatation was performed with a 2.0 non-bsc balloon catheter.Subsequently, a 20x3.00mm promus premier¿ stent was advanced to treat the lesion, however, resistance was encountered and the device was unable to cross the lesion.When the physician removed the device, it was noted that the stent struts were lifted and presence of a black adhesion substance on the lifted portion of the stent.The procedure was completed with a 16x3.0mm promus premier¿ stent.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: the stent delivery system was returned for analysis.A visual examination of the crimped stent found stent struts on the distal portion of the crimped stent were distorted, damaged & stretched distally out over the distal markerband.This type of damage is consistent with resistance being experienced during withdrawal or where interaction with another device has occurred.The bumper tip of the device showed no signs of damage.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.During examination of the damaged stent and balloon, no fm other than solidified blood was identified.The balloon was inflated to expand the stent to enable a thorough review of the damaged stent.The review concluded that solidified blood was caught between the stent struts.This type of build-up is consistent with a device that had entered a patient¿s body.There were no issues with the performance of the balloon during inflation/deflation attempts.A visual and tactile examination found no issues with the hypotube shaft profile and shaft polymer extrusion profile.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 most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that stent damage and foreign matter occurred.The target lesion was located in the mildly tortuous left circumflex artery (lcx).A non-bsc stent was implanted in the ostial left anterior descending artery (lad) for more than 10 years ago and it was noted that the edge of the device was slightly deployed in left main trunk (lmt).Pre-dilatation was performed with a 2.0 non-bsc balloon catheter.Subsequently, a 20x3.00mm promus premier stent was advanced to treat the lesion, however, resistance was encountered and the device was unable to cross the lesion.When the physician removed the device, it was noted that the stent struts were lifted and presence of a black adhesion substance on the lifted portion of the stent.The procedure was completed with a 16x3.0mm promus premier stent.No patient complications were reported and the patient's status was good.

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4735703
• MDR Text Key: 5585451
• Report Number: 2134265-2015-02371
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2016
• Device Model Number: H7493925120300
• Device Catalogue Number: 39251-2030
• Device Lot Number: 17441282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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
• Treatment: GUIDE WIRE: RUNTHROUGHNS, SION; GUIDING CATHETER: MACH1