MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550350-38
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The stent remains in patient but the delivery system will be returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The trek balloon referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a calcified lesion in the tortuous distal right coronary artery (rca).The 3.50x38 mm xience sierra stent delivery system (sds) was being attempted to be placed distally; however, it could not cross the mid part of the vessel due to calcification.The physician wanted to remove the sds to pre-dilate the distal part of the vessel so the sds was removed.It was not noted that the stent had dislodged until pre-dilatation was being performed with the 3.50x20 mm trek balloon dilatation catheter (bdc) in the distal vessel and it was seen on angiography.Negative pressure was held for 2 seconds; however, the bdc would not completely deflate and became stuck in the same area as the stent in the calcification.Additionally, the balloon separated from the catheter.Multiple wire attempts were performed to try to remove the stent and balloon but were unsuccessful.Both the stent and balloon remain stuck in calcification in the vessel.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the calcified lesion and tortuous artery causing the reported failure to advance.During removal the stent interacted with the lesion calcification causing the reported stent dislodgement with the treatment of additional therapy non-surgical treatment and patient effect of foreign body in patient.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9572158
• Report Number: 2024168-2020-00527
• Device Sequence Number: 18947082
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 03/24/2020

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: 08/15/2020
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 9081241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/24/2020
• 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: 3.50X20MM TREK BALLOON DILATATION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR