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

Catalog Number 1500350-23

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Intimal Dissection (1333); Cardiac Enzyme Elevation (1838); Occlusion (1984); Prolapse (2475)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

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 effects of intimal dissection, prolapse and occlusion are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported wall apposition; however, factors that may contribute to patient-device incompatibility (wall apposition) include, but are not limited to, interaction with insufficient post-dilation, incorrect device size for lesion, patient anatomical morphology, and patient disease state.The reported patient effects of intimal dissection, prolapse, occlusion and additional therapy/non-surgical treatment appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other xience sierra device is filed under a separate medwatch report number.

Event Description

Patient id: (b)(4).It was reported that on (b)(6) 2020, the patient underwent a coronary procedure, performed to treat a lesion in the mid left anterior descending (lad) artery.Two xience sierra stents, a 3.5 x 23 mm and a 3.5 x 28 mm, were implanted.During implantation of the 3.5 x 23 mm xience sierra stent, the second diagonal artery was lost.Additionally, stent malposition and plaque shift occurred with both implanted stents.Edge dissection was noted at the distal stent, the 3.5 x 23 mm xience sierra.Additional balloon dilatation was performed to treat the adverse patient effects and the event resolved on (b)(6) 2020.No additional information was provided.

Manufacturer Narrative

The reported patient effects of intimal dissection, prolapse, occlusion, enzyme elevation and additional therapy/non-surgical treatment appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: post procedure, cardiac enzymes were noted to be elevated.Per study physician, the enzyme elevation was related to the 3.5 x 23 mm xience sierra stent.No treatment was provided and the event resolved on (b)(6) 2020.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9998826
• MDR Text Key: 189842772
• Report Number: 2024168-2020-03916
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Catalogue Number: 1500350-23
• Device Lot Number: 9091641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.5X28 MM XIENCE SIERRA
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 115