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

Model Number H7493925116220

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Age at time of event: 18 years or older.(b)(6).(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported that there was a hole in the catheter shaft.The target lesion was located in the first diagonal artery and circumflex artery.A 16x2.25mm promus premier¿ stent was selected for use.However, prior entering the guide catheter, a hole was noticed 5cm from the "ball".This was distal from the original exit hole which prevents the device from being advanced further.The device was replaced and the procedure was completed another stent.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: promus premier mr us 2.50 x 38mm stent delivery system 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 found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues.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 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 there was a hole in the catheter shaft.The target lesion was located in the first diagonal artery and circumflex artery.A 16x2.25mm promus premier stent was selected for use.However, prior entering the guide catheter, a hole was noticed 5cm from the "ball".This was distal from the original exit hole which prevents the device from being advanced further.The device was replaced and the procedure was completed another stent.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: 7518750
• MDR Text Key: 108409528
• Report Number: 2134265-2018-04282
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2019
• Device Model Number: H7493925116220
• Device Catalogue Number: 39251-1622
• Device Lot Number: 0021171772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• 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
• Patient Age: 60 YR