MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1550225-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	02/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 effect of dissection is listed in the xience sierra, everolimus eluting coronary stent systems instructions for use, as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect 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.The 2.25x18mm (8120341) and 2.5x28mm xience sierra (8102441) stents referenced are filed under separate medwatch reports.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient was admitted with st elevation myocardial infarction, thrombus and cardiac arrest.A 2.25 x 18 mm xience sierra stent (8120341) and a 2.5 x 28 mm xience sierra stent (8102441) were implanted in the proximal left anterior descending (lad) artery.Sluggish flow was noted after stent deployment; however, no additional intervention was performed.On (b)(6) 2019, the patient experienced ventricular tachycardia and was taken back to the cath lab.Coronary angiography noted thrombus in the stented segment.A 2.5 x 33 mm xience sierra stent and a 2.25 x 12 mm xience sierra stent (8090341) were implanted to treat the thrombus.Post dilatation was performed using an unspecified nc dilatation catheter.A non-flow limiting edge dissection was noted at the 2.25 x 12 mm xience sierra stent.No additional intervention was performed to treat the dissection.Post procedure, the patient was in stable condition.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8561593
• Report Number: 2024168-2019-03380
• Device Sequence Number: 13912488
• Product Code: NIQ
• UDI-Device Identifier: 08717648227004
• UDI-Public: 08717648227004
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 09/10/2019
• Device Catalogue Number: 1550225-12
• Device Lot Number: 8090341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/29/2019
• 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: STENT: XIENCE SIERRA 2.25X18, 2.5X28
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR