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

Model Number H7493911324400

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that stent explantation occurred.The 80% stenosed target lesion was located in the mid right coronary artery (rca).A guidezilla¿ guide extension catheter was advanced however, resistance was encountered.An "unspectical" balloon catheter was used to resolve the issue and a non-bsc stent was implanted.However, the non-bsc stent was noted to be damaged by the guidezilla¿.The implanted non-bsc stent was removed and was exchanged with a 4.00 x24mm promus element ¿ stent.Following implantation of the 4.00 x24mm promus element ¿ stent, the stent was noted to be extruded by the guidezilla¿.The promus element ¿ stent and the guidezilla¿ were then removed and the procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the stent appeared to be partially deployed as some stent struts were no longer in crimp state on the balloon, stent struts were damaged and pushed towards the distal end of balloon body; some stent struts over the distal markerband.Stent damage most likely occurred when the stent got in contact with the guidezilla.The distal edge of the bumper tip of the device showed signs of very slight damage.This type of damage is consistent with excessive force being applied to the delivery system.The balloon body was reviewed and no issues were noted with the overall balloon.Crimp markings were evident on the exposed balloon body and balloon wings appeared relaxed.A visual and tactile examination found no kinks along the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found a kink in the inner extrusion within 0.5 -1cm proximal of the proximal bond.The bi-component bond showed no signs of damage or strain.This type of damage is consistent with excessive force being applied to the delivery system.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 cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

It was reported that stent explantation occurred.The 80% stenosed target lesion was located in the mid right coronary artery (rca).A guidezilla¿ guide extension catheter was advanced however, resistance was encountered.An "unspectical" balloon catheter was used to resolve the issue and a non-bsc stent was implanted.However, the non-bsc stent was noted to be damaged by the guidezilla¿.The implanted non-bsc stent was removed and was exchanged with a 4.00 x24mm promus element ¿ stent.Following implantation of the 4.00 x24mm promus element ¿ stent, the stent was noted to be extruded by the guidezilla¿.The promus element ¿ stent and the guidezilla¿ were then removed and the procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS ELEMENT ¿
• 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: 6197890
• MDR Text Key: 63065702
• Report Number: 2134265-2016-12092
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2017
• Device Model Number: H7493911324400
• Device Catalogue Number: 39113-2440
• Device Lot Number: 19123346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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
• Treatment: GUIDEZILLA¿ GUIDE EXTENSION CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR