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

Catalog Number	1550325-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
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.The reported patient effects of angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019 the 3.25x23 xience sierra stent was implanted in the proximal left circumflex (lcx) coronary artery.On (b)(6) 2019 the patient was re-admitted to the hospital with radiating chest pain to the shoulders on exertion.The patient experienced relief from the pain with rest.A diagnostic angiogram on (b)(6) 2019 revealed triple vessel disease with 90% disease in the proximal lcx, left anterior descending, and ramus arteries.Four coronary arteries, the ramus, diagonal, first obtuse marginal, and left posterolateral, were surgically bypassed on (b)(6) 2019.Although there was no restenosis inside the xience stent, there was stenosis within 5 mm of the stent.The condition resolved without sequelae on (b)(6) 2019.No additional information was 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: 9169016
• Report Number: 2024168-2019-12440
• Device Sequence Number: 2657576
• Product Code: NIQ
• UDI-Device Identifier: 08717648227356
• UDI-Public: 08717648227356
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 10/08/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2019
• Device Catalogue Number: 1550325-23
• Device Lot Number: 8102541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/08/2019
• 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: 72 YR
• Patient Weight: 101