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	H7493926008400
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that deployment issues and stent migration occurred.The chronic totally occluded (cto) target lesion was located in the distal right coronary artery (rca).An 8f guide catheter was used in the rca via a right femoral sheath, a 7f guide catheter was used for the left coronary system via a left radial sheath, and a 185 cm guide wire was advanced into the rca to the proximal cap of the cto.It was decided to stent the ostial/proximal rca with a 4.00 x 8 mm synergy ii drug-eluting stent prior to attempting the distal rca cto.The stent was deployed at 16 atmospheres for 18 seconds and the guide was disengaged for the deployment of the stent.While attempting to engage the guide back in the rca, it was noted that the stent was entangled with the 8f guide catheter.The guide catheter was through a stent strut and the stent was hugging the guide.The physician thought the stent had watermelon seeded back into the aorta during deployment and got caught up in the guide catheter during the attempt to re-engage the rca.The 7f guide catheter was exchanged for another and a 30 mm snare was inserted via the new 7f guide catheter.After multiple snaring attempts of the 8f guide catheter and subsequently the stent, it was noticed on fluoroscopy that the stent was no longer on the guide catheter.A scan using fluoroscopy and cinematography was performed on the patient¿s head/neck, upper extremities, chest/abdomen and femoral/iliac regions in search of the stent.There was no visual of the stent during this time.The snare was removed and assessed with no evidence of the stent.The guide catheters were also removed and assessed with no evidence of the stent.The physician decided to suture in the femoral sheath and sent the patient to radiology for further imaging to locate where the stent migrated to in the body.The stent was not located with x-ray images in radiology.No further patient complications were reported and the patient remained stable throughout the procedure.The patient was doing well and will return for a repeat attempt at the cto lesion.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7373515
• Report Number: 2134265-2018-02245
• Device Sequence Number: 1556693
• Product Code: NIQ
• UDI-Device Identifier: 08714729840015
• UDI-Public: 08714729840015
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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
• Report Date (Section B): 03/01/2018

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: 11/15/2018
• Device Model Number: H7493926008400
• Device Catalogue Number: 39260-0840
• Device Lot Number: 0021420795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/27/2018
• 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: 7F EBU 4 GUIDE CATHETER; 7F MP GUIDE CATHETER; 8F AL1 GUIDE; AMPLATZ GOOSE NECK 30MM SNARE; FORTE MODERATE 185CM WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR