MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2023

Event Type  Injury  

Manufacturer Narrative

The device history record for the reported oad could not be reviewed as the lot number was not provided.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.H6: investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a vascular dissection is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).

Event Description

A peripheral orbital atherectomy device (oad) and viperwire advance guide wire were used to treat a lesion in the left anterior tibial (at) artery via right common femoral artery.The oad could not cross through the popliteal without making a channel.Treatment was performed throughout the anterior tibial.Following balloon angioplasty, a large flow-limiting dissection in the proximal at was observed.Placement of a drug-eluting stent and a covered stent were performed followed by post dilation to resolve the dissection.According to the physician, the dissection likely contributed from a peroneal collateral.The patient was stable.

Manufacturer Narrative

Csi device did not cause or contribute to the dissection, therefore this event is no longer reportable for the csi device.

Event Description

Additional information: dissection was seen on x-ray.According to the physician, csi device did not cause or contribute to the dissection.

• Type of Device: PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18025893
• MDR Text Key: 326797110
• Report Number: 3004742232-2023-00264
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White