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

Catalog Number	1550300-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Dyspnea (1816); Myocardial Infarction (1969); Dyskinesia (2363)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for analysis.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 reported patient effect of myocardial infarction is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, factors that may contribute to patient-device incompatibility (wall apposition) include, but are not limited to, incorrect device size for lesion, patient anatomical morphology, and patient disease state, and insufficient post-dilation.The reported patient effects and treatment appear to be related to operational context of the procedure as it is likely the under deployed stent caused the reported myocardial infarction, dyspnea, dyskinesia, clamminess, additional therapy/non-surgical treatment and hospitalization.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Study patient (b)(6).It was reported that the procedure was performed on (b)(6) 2019, treating a target lesion in the mid left anterior descending (lad) artery.The 3.0 x 15 mm xience sierra stent was implanted without issue.On (b)(6) 2019, the patient was working at home and developed difficulty breathing and shivering, with clamminess.Emergency medical services was called and administered aspirin.The patient was transported to the emergency department and hospitalized.The patient was hemodynamically stable.Troponin levels were elevated and non-st elevation myocardial infarction was diagnosed.The patient was taken to the cath lab and coronary angiography noted that the stent was underdeployed.Balloon angioplasty was performed.Antiplatelet medications were administered.The patient was observed for two days.The event resolved on 11/16/2019 and the patient was discharged to home.There was no additional information provided.

• 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: 9454870
• Report Number: 2024168-2019-14416
• Device Sequence Number: 2089971
• Product Code: NIQ
• UDI-Device Identifier: 08717648227257
• UDI-Public: 08717648227257
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: 09/12/2019
• Device Catalogue Number: 1550300-15
• Device Lot Number: 8090541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/11/2019
• 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; Required Intervention; Disability
• Patient Age: 88 YR
• Patient Weight: 67