MAUDE Adverse Event Report: ABBOTT VASCULAR RX XIENCE XPEDITION 48; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070350-48

Device Problem Deflation Problem (1149)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a de novo mid-distal right coronary artery.A 3.5x48mm xience xpedition device was advanced to the lesion and deployed at 10 atmospheres, however post deployment, the balloon deflated after a prolonged period of time (3-4 minutes), causing a delay which led to the patient experiencing hypotension.Medication was provided.Multiple attempts of applying negative pressure to the indeflator to deflate the balloon were performed.The balloon ultimately deflated before being removed from the anatomy.The patient was stable once the balloon was deflated.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deflation issues were not confirmed.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 hypotension is listed in the xience xpedition 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 deflation issue as the device deflated without issue during return evaluation.Balloon deflation can be affected by, but not limited to, contrast mixing, bent/kinked shaft while inside the anatomy affecting the inflation/deflation lumen and/or stretched outer member (om) thereby reducing the inflation/deflation lumen.In this case, outer member stretching was noted during return analysis which appeared to be related to operational context.The noted outer member stretching in combination with patient¿s anatomy may have contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX XIENCE XPEDITION 48
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10931582
• MDR Text Key: 219138848
• Report Number: 2024168-2020-10075
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Catalogue Number: 1070350-48
• Device Lot Number: 0012741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention