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

Model Number	1550400-38
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Respiratory Failure (2484)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is currently retained by the hospital, but is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a high grade stenosis in the proximal through mid right coronary artery (rca).While the 4.0x38 mm xience sierra stent was being deployed the balloon ruptured at 8 atmospheres and the stent dislodged.The proximal end of the stent was expanded about 1 mm.The delivery system was able to be removed after some work and multiple balloons were used to dilate the severely under-expanded stent in the target lesion.At this point the patient went asystolic, but was able to be resuscitated.Once stable, the 4.00x38 mm xience sierra was overlapped with another 4.0x18 mm xience sierra.A 4.00mm non compliant non-abbott balloon was used to complete post-dilatation of both of the stents.There were no issues reported with the 4.0x18 mm xience sierra stent.The patient is intubated and is in the intensive care unit.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stent dislodgement was confirmed.The reported material rupture was not confirmed.The reported difficulty to remove 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.The reported material rupture was not confirmed during return analysis; however, a tip leak and inner member tear were noted and were likely misidentified as a material rupture by the account.The noted tip leak/inner member tear were likely the cause of the reported difficulties.Scanning electron microscope (sem) was used to further investigate the tip leak, the sem analysis stated, the inner member exhibited torn, stretched and thinned material near the proximal end of the distal seal resulting in the tip leak.Mechanical damage/pushed material was observed along the inner surface proximal to the leak and may have contributed to the failure mechanism.It should be noted that the device was prepped outside of the anatomy without issue prior to use which indicated the noted damage occurred after device preparation.It is likely the tip/inner member damage noted during sem analysis occurred due to inadvertent interaction with the guide wire during the procedure causing the noted damage.The device partially inflated due to the leak causing the stent dislodgement during removal.The delayed deflation due to the noted tip leak/inner member tear likely caused the reported difficulty to remove.Additionally, the reported patient effect and treatments appear to be related to operational context of the procedure.The reported patient effect of respiratory arrest is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10438155
• Report Number: 2024168-2020-06999
• Device Sequence Number: 2795333
• Product Code: NIQ
• UDI-Device Identifier: 08717648227547
• UDI-Public: 08717648227547
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 04/06/2021
• Device Model Number: 1550400-38
• Device Catalogue Number: 1550400-38
• Device Lot Number: 0032741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 58