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

Model Number	H7493952812400
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(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 medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id 2134265-2018-02450.It was reported that stent damage occurred.The target lesion was located in the right coronary artery.After a 6f jr4 runway guide catheter was in place, a 4.00x12mm promus premier¿ drug-eluting stent was advanced but it was noted that the stent got caught with the guide catheter and was damaged.The device was removed and a 4.00x32mm promus premier¿ drug-eluting stent was then advanced; however, the stent got caught with the guide catheter and the physician felt that the second stent was damaged as well.The guide catheter was pulled out and a new guide catheter was then utilize to successfully deploy the stents.No patient complications were reported and the patient's status was great.
Additional Manufacturer Narrative
Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes and conclusion codes updated.Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the distal stent rows 1-2 were damaged with stent struts lifted and pulled distally.The undamaged crimped stent outer diameter (od) was measured and is within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip showed signs of damage.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the device found no issues along the mid shaft, inner or outer polymer extrusion.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
Same case as mdr id 2134265-2018-02450.It was reported that stent damage occurred.The target lesion was located in the right coronary artery.After a 6f jr4 runway guide catheter was in place, a 4.00x12mm promus premier¿ drug-eluting stent was advanced but it was noted that the stent got caught with the guide catheter and was damaged.The device was removed and a 4.00x32mm promus premier¿ drug-eluting stent was then advanced; however, the stent got caught with the guide catheter and the physician felt that the second stent was damaged as well.The guide catheter was pulled out and a new guide catheter was then utilize to successfully deploy the stents.No patient complications were reported and the patient's status was great.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7396293
• Report Number: 2134265-2018-02449
• Device Sequence Number: 13484691
• Product Code: NIQ
• UDI-Device Identifier: 08714729844693
• UDI-Public: 08714729844693
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493952812400
• Device Catalogue Number: 39528-1240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 6F JR4 RUNWAY