MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926020300

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.  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 Description

It was reported that a foreign matter was found on the device.A 3.00 x 20 mm synergy ii drug-eluting stent was selected for use.However, during unpacking, a piece of lint was found on the device.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: synergy ii us mr 3.00 x 20mm stent delivery system was returned for analysis.The device was examined upon receipt before the decontamination process and there was no evidence of foreign matter (fm) on the device, in the inner foil pouch or in the outer box packaging.The device was examined thoroughly under microscope there was no fm evident on the device.A visual examination of the crimped stent found no issues.There were no signs of damage, lifting or stretching of the stent struts.The crimped stent od (outer diameter) was measured and the result was 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 device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and slight damage was noted.No other issues were identified during the product analysis.A review of documentation was performed to ensure that all required in-process and final inspection and testing have been completed and all acceptance criteria are met.There is no evidence that the device failed to meet specification prior to shipping.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that a foreign matter was found on the device.A 3.00x20mm synergy ii drug-eluting stent was selected for use.However, during unpacking, a piece of lint was found on the device.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6808475
• MDR Text Key: 83202870
• Report Number: 2134265-2017-08530
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: (01)08714729840176(17)20180614(10)0020808554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: H7493926020300
• Device Catalogue Number: 39260-2030
• Device Lot Number: 0020808554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR