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

Model Number H7493925138250

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2016

Event Type  malfunction  

Manufacturer Narrative

Device is combination product.(b)(4).Device evaluated by mfr.: the promus premier ous mr 38 x 2.50 stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found damage to the first distal strut, the strut was raised from balloon profile in a proximal direction.The bumper tip of the device showed signs of damage to the edge of the tip.The tip edge had lifted on one side.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.A visual and tactile examination found several hypotube kinks along the shaft profile.A visual and tactile examination found no issues with the shaft polymer extrusion profile.No difficulties were experienced while tracking the device over a 0.014" guide wire.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

Reportable based on device analysis completed on 16may2016.It was reported that crossing difficulties and difficulty tracking over wire were encountered.Vascular access was obtained via the right femoral artery.The 70-90% stenosed, 32x2.25-2.5mm, concentric, de novo target lesion containing a lesion bend of >=90 degrees was located in the severely tortuous and moderately calcified left circumflex (lcx) artery and ostium of first obtuse marginal (om) branch.The physician cannulated the ostium with a 6f 3.5 guide catheter and a non-bsc guide wire crossed the lesion.A buddy wire was utilized and then predilation was performed with a 2x12 balloon.Following predilation, residual stenosis was 30-40%.It was noted that the physician had great difficulty tracking the balloon after predilation and wanted to use a good trackable stent.A 2.5 x38 promus premier¿ stent was advanced but had difficulty tracking down from lcx and the stent could not track down to the om.The device was removed and non-bsc guide wire was exchanged with another non-bsc guide wire and a guidezilla¿ guide extension catheter was used to have better control for deliver.However, neither the guidezilla¿ nor the promus premier¿ stent was able to track.Predilation was again performed using a 2.5x8 nc quantum apex¿ balloon catheter.A 2.25x12 non-bsc stent was then advanced.However, both the non-bsc stent and promus premier¿ stent failed to cross and resistance was noted at the lcx.A 2.5x12 non-bsc stent was successfully deployed and the result was good with timi f3 flow and the procedure was completed.No patient complications were reported and the patient's status was stable.However, device analysis revealed a distal stent damage.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5722350
• MDR Text Key: 47288925
• Report Number: 2134265-2016-04882
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2016
• Device Model Number: H7493925138250
• Device Catalogue Number: 39251-3825
• Device Lot Number: 0018057242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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: 2 RUNTHROUGH ,1 FIELDER GUIDE WIRE
• Patient Age: 45 YR