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

Model Number	H7493952816400
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-01671.It was reported that the stent damage occurred.The target lesion was located in the right coronary artery (rca).A 4.00x32mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent bunched up in the middle of the balloon and slid a couple of millimeters off the end of the balloon.The proximal end of the stent was half way down the balloon.To prevent the stent to be dislodged from the balloon, the physician deployed the stent to where it was.The physician then dilated the first stent after it was deployed.The physician advanced a 4.00x16mm promus premier¿ drug-eluting stent but there was difficulty passing through the first deployed stent.While pulling the second stent out, it hung up on the first stent and the first stent hung up on the guide.The second stent had a burr in the middle of the stent.A non-bsc guide extension catheter was then advanced and another promus stent was delivered which completed the procedure.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: fg,promus premier,us, mr 4.00x16mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.Two central stent strut rows were partially lifted from the stent profile and pulled in a distal direction.The stent showed no signs of movement and was set equidistant between the proximal and distal marker bands.The crimped stent od(outer diameter) was measured and the result is within max crimped stent profile measurement.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 hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.The bi-component bond showed no signs of damage or strain.A visual and microscopic examination found damage to the tip.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 or Problem Description
Same case as mdr id: 2134265-2017-01671 it was reported that the stent damage occurred.The target lesion was located in the right coronary artery (rca).A 4.00x32mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent bunched up in the middle of the balloon and slid a couple of millimeters off the end of the balloon.The proximal end of the stent was half way down the balloon.To prevent the stent to be dislodged from the balloon, the physician deployed the stent to where it was.The physician then dilated the first stent after it was deployed.The physician advanced a 4.00x16mm promus premier¿ drug-eluting stent but there was difficulty passing through the first deployed stent.While pulling the second stent out, it hung up on the first stent and the first stent hung up on the guide.The second stent had a burr in the middle of the stent.A non-bsc guide extension catheter was then advanced and another promus stent was delivered which completed the procedure.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6385244
• Report Number: 2134265-2017-01716
• Device Sequence Number: 18963088
• Product Code: NIQ
• UDI-Device Identifier: 08714729844754
• UDI-Public: (01)08714729844754(17)20180107(10)19502064
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/14/2017

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 Expiration Date: 01/07/2018
• Device Model Number: H7493952816400
• Device Catalogue Number: 39528-1640
• Device Lot Number: 19502064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 03/24/2017
• 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: STENT: 4.00X32MM PROMUS PREMIER