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

Model Number	1550225-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of myocardial infarction and death are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019 the 2.25x12 mm xience sierra stent was implanted in the first diagonal artery and the 2.5x15 mm xience sierra stent was implanted in the distal right coronary artery.On (b)(6) 2020 the patient had a myocardial infarction and expired.No treatment was given.There is a possible device relationship.No additional information was provided.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019 the 2.25x12 mm xience sierra stent was implanted in the first diagonal artery and the 2.5x15 mm xience sierra stent was implanted in the distal right coronary artery.On (b)(6) 2020 the patient had a myocardial infarction and expired.No treatment was given.There is a possible device relationship.Subsequent to the previously filed report, additional information was received indicating that the myocardial infarction and subsequent death are not related to the xience sierra stent.The patient was doing fine until the patient suddenly died at home.The patient was pronounced dead and was taken directly to the funeral home.There was no hospitalization.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.No investigation required.There were no specific reported device malfunctions or patient effects associated with the device.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.H6: patient codes 1969 and 1802 were removed and replaced with 2199.H6: results code 213 was removed and replaced with 3221.H6: conclusion code 22 was removed and replaced with 4315.

• 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: 10254096
• Report Number: 2024168-2020-05615
• Device Sequence Number: 596819
• Product Code: NIQ
• UDI-Device Identifier: 08717648227004
• UDI-Public: 08717648227004
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2019
• Device Model Number: 1550225-12
• Device Catalogue Number: 1550225-12
• Device Lot Number: 8120541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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: 2.5X15 MM XIENCE SIERRA; 2.5X15 MM XIENCE SIERRA
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Weight: 82