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

Model Number	H7493952838250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.A 2.50x38mm promus premier drug-eluting stent was advanced to treat the lesion.However, the hypotube was broken.The device was completely removed from the patient's body by simply pulling out through the sheath.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual and tactile examination found several hypotube kinks and the shaft itself was broken at 615mm distal from the distal edge of the strain relief.The break most likely occurred due to the application of excessive force which may have initially kinked the device and then resulted in the hypotube breaking.A visual and tactile examination found one outer extrusion and inner lumen kink just distal to the port bond.This type of damage is likely to have been caused by excessive tensile force being applied to the delivery system.The midshaft section and bi-component bond showed no signs of damage or strain.A visual examination of the crimped stent found no issues with the crimped stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent outer diameter (od) was measured and the reading is within specification.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.The bumper tip of the device showed no signs of damage.No other issues were identified during 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 shaft break occurred.A 2.50x38mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the hypotube was broken.The device was completely removed from the patient's body by simply pulling out through the sheath.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6121067
• Report Number: 2134265-2016-10362
• Device Sequence Number: 787191
• Product Code: NIQ
• UDI-Device Identifier: 08714729845003
• UDI-Public: (01)08714729845003(17)20171126(10)19341247
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/25/2016

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: 11/26/2017
• Device Model Number: H7493952838250
• Device Catalogue Number: 39528-3825
• Device Lot Number: 19341247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1