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

Model Number	H7493952824220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a severely tortuous and severely calcified left anterior descending (lad) artery to diagonal artery branch.A 3.00x38mm promus premier¿ drug-eluting stent was advanced to treat the lad; however, it failed to cross the lesion.The physician took another 2.25x24mm promus premier¿ drug-eluting stent to treat the lesion in the diagonal artery branch.Following pre-dilatation, the device was advanced; however, the stent would not cross the lesion.Further dilatation was performed and eventually, the stent came off the balloon.The stent was noted inside the guide catheter and the device was removed from the patient's body as a whole together with the guide catheter and wire with no issues.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg promus premier us mr 2.25x24mm stent delivery system (sds) was returned for analysis with a detached stent.A visual and microscopic examination of the crimped stent found that the stent had been damaged and separated from the delivery system.Damage was noted across the entire detached stent wit with most severe damage to the middle and distal sections of the stent which had been severely damaged and squashed.The balloon was reviewed.There was no stent on the balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp markings were evident on the balloon indicating correct positioning and crimping of the stent prior to the complaint incident.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.A visual and microscopic examination found no damage to the tip.No other issues were identified during the product analysis.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 dislodgement occurred.The target lesion was located in a severely tortuous and severely calcified left anterior descending (lad) artery to diagonal artery branch.A 3.00x38mm promus premier drug-eluting stent was advanced to treat the lad; however, it failed to cross the lesion.The physician took another 2.25x24mm promus premier drug-eluting stent to treat the lesion in the diagonal artery branch.Following pre-dilatation, the device was advanced; however, the stent would not cross the lesion.Further dilatation was performed and eventually, the stent came off the balloon.The stent was noted inside the guide catheter and the device was removed from the patient's body as a whole together with the guide catheter and wire with no issues.The procedure was completed with a different device.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: 6843466
• Report Number: 2134265-2017-09010
• Device Sequence Number: 656001
• Product Code: NIQ
• UDI-Device Identifier: 08714729844822
• UDI-Public: (01)08714729844822(17)20180626(10)0020119961
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/22/2017

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: 06/26/2018
• Device Model Number: H7493952824220
• Device Catalogue Number: 39528-2422
• Device Lot Number: 0020119961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1