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

Model Number	H7493952808270
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the highly calcified left anterior descending (lad) artery.After pre-dilatation was performed, a 2.75x8mm promus premier drug-eluting stent was advanced to treat the lesion.However, the stent was caught by the calcification and the stent came off the catheter.The stent was left sticking to the lesion and undeployed.No patient complications were reported and the patient's status was fine.Currently, the patient is being treated medically.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.The stent detached from the delivery system and remained inside the patient¿s body therefore was not returned for analysis.The distal edge of the bumper tip of the device showed signs of damage.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were relaxed and appeared as if positive pressure was applied.Solidified media was evident inside the balloon chamber and crimp markings were not prominent on the balloon wall.A visual and tactile examination found multiple kinks along the hypotube shaft.These types of damage are consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.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
It was reported that stent dislodgment occurred.The target lesion was located in the highly calcified left anterior descending (lad) artery.After pre-dilatation was performed, a 2.75x8mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the stent was caught by the calcification and the stent came off the catheter.The stent was left sticking to the lesion and undeployed.No patient complications were reported and the patient's status was fine.Currently, the patient is being treated medically.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6149428
• Report Number: 2134265-2016-11102
• Device Sequence Number: 893421
• Product Code: NIQ
• UDI-Device Identifier: 08714729844600
• UDI-Public: (01)08714729844600(17)20170220(10)18370221
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/16/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2017
• Device Model Number: H7493952808270
• Device Catalogue Number: 39528-0827
• Device Lot Number: 18370221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention